The list of Covid-19 Antibody, Antigen and Nucleic Acid Amplification Test (NAAT) that is recommended for use based on the decision on the consensus of the Covid-19 Test Kit Expert committee is as follows.
All test submissions are scored according to: -
- the manufacturer reported clinical and analytical performance
- the evaluation test results from testing facilities are according to the committee evaluation criteria set by Clinical expert
- Supporting Documents for COVID-19 IVD Test Kits Special Access
Below is the list of all tests that have been selected to date and the status is Recommended for Use (please note: list is updated on a routine basis).
Notes:
*Sample type and lot number is based on testing facility evaluation report.
|
NO |
COMPANY NAME |
PRODUCT NAME |
MANUFACTURER |
IDENTIFIER |
LOT NUMBER* |
DETECTION |
SAMPLE TYPE* |
|
1. |
Science Valley Sdn Bhd |
STANDARD™ Q COVID-19 Ag Test |
SD Biosensor, Inc. Republic of Korea |
Reference No: Q-NCOV-01G Catalogue No: 09COV30D |
QC03020019A |
RTK Antigen |
Nasopharyngeal or oropharyngeal swab samples |
|
2 |
NeoScience Sdn Bhd |
NowCheck Covid-19 Ag Test |
BioNote, Inc. Republic of Korea |
RG1901DG |
1901D001 |
RTK Antigen |
Nasopharyngeal or oropharyngeal swab samples |
|
3 |
Axisbio Diagnostic Sdn Bhd |
Quidel SOFIA 2 SARS Antigen FIA |
Quidel Corporation. CA, USA |
20374 |
141493 |
RTK Antigen |
Nasopharyngeal or oropharyngeal swab samples |
|
4 |
Science Valley Sdn Bhd |
STANDARD F COVID-19 Ag FIA |
SD Biosensor, Inc. Republic of Korea |
Reference No.: F-NCOV-01G |
FCO302006041 |
RTK Antigen |
Nasopharyngeal or oropharyngeal swab samples |
|
5 |
Premier Diagnostics Sdn Bhd |
ecotest COVID-19 Antigen Rapid Test Device (Respiratory Specimens) |
Assure Tech. (Hangzhou) Co., Ltd. P.R. China |
cov-w23M |
SR20070002 |
RTK Antigen |
Nasopharyngeal or oropharyngeal swab samples |
|
6 |
Alere Health Sdn Bhd / Abbott Laboratories |
Panbio™ COVID-19 Ag Rapid Test Device |
Abbott Rapid Diagnostics Jena GmbH Germany |
41FK10 |
N/A |
RTK Antigen |
Nasopharyngeal or oropharyngeal swab samples |
|
7 |
Citymedic Sdn Bhd |
Gmate® COVID-19 Ag |
Philosys Co., Ltd Republic of Korea |
AG-019 |
20200922 |
RTK Antigen |
Nasopharyngeal or oropharyngeal swab samples |
|
8 |
Roche Diagnostics (M) Sdn Bhd |
SARS-CoV-2 Rapid Antigen Test |
SD Biosensor Republic of Korea |
9901-NCOV-01G |
QCO3020109 |
RTK Antigen |
Nasopharyngeal or oropharyngeal swab samples |
|
9 |
Medical Innovation Ventures Sdn Bhd |
ProDetect® COVID-19 Antigen Rapid Test |
Medical Innovation Ventures Sdn. Bhd. Penang, Malaysia |
PR-CVDAg |
PRCVDCAg20NOV04 |
RTK Antigen |
Nasopharyngeal or oropharyngeal swab samples |
|
10 |
Klinik Gemilang |
VivaDiag™ SARS-CoV-2 Ag Rapid Test |
VivaChek Biotech (Hangzhou) Co., Ltd. P.R. China |
VCD05-01-011 |
SE2010016 |
RTK Antigen |
Nasopharyngeal or oropharyngeal swab samples |
|
11 |
Everest Medical Resources (M) Sdn Bhd |
VivaDiag™ SARS-CoV-2 Ag Rapid Test |
VivaChek Biotech (Hangzhou) Co., Ltd. P.R. China |
VCD05-01-011 |
SYE2009027 |
RTK Antigen |
Nasopharyngeal or oropharyngeal swab samples |
|
12 |
Malaysian Diagnostics Corporation Sdn Bhd |
SGTi-flex COVID-19 Ag |
Sugentech, Inc. Republic of Korea |
CAGT-0xx-O CAGT-0xxEx |
CAGT20002 |
RTK Antigen |
Nasopharyngeal or oropharyngeal swab samples |
|
13 |
MYEG Medical Service Sdn Bhd |
SGTi-flex COVID-19 Ag |
Sugentech, Inc. Republic of Korea |
CAGT-0xx-O CAGT-0xxEx |
N/A |
RTK Antigen |
Nasopharyngeal or oropharyngeal swab samples |
|
14 |
EB Holdings Sdn Bhd |
SGTi-flex COVID-19 Ag |
Sugentech, Inc. Republic of Korea |
CAGT-0xx-O CAGT-0xxEx |
CAGT20004 |
RTK Antigen |
Nasopharyngeal or oropharyngeal swab samples |
|
15 |
Malaysian Diagnostics Corporation Sdn Bhd |
Humasis COVID-19 Ag Test |
Humasis Co., Ltd., Republic of Korea. |
ACOVA-7025 |
COVGNP0001 |
RTK Antigen |
Nasopharyngeal or oropharyngeal swab samples |
|
16 |
Merlin Medic Sdn Bhd |
Healgen® Coronavirus Ag Rapid Test Cassette (Swab) |
Healgen Scientific Limited Liability Company, USA |
N/A |
2011390 |
RTK Antigen |
Nasopharyngeal or oropharyngeal swab samples |
|
17 |
Arey Solutions Sdn Bhd |
DIAKEY COVID-19 Ag Rapid Test |
Shinjin Medics Inc. Republic of Korea |
PF10 |
E272001A01 |
RTK Antigen |
Nasopharyngeal or oropharyngeal swab samples |
|
18 |
Daiichi Biotech Services Sdn Bhd |
UNICELL-2019-nCoV Ag |
Shenzhen YHLO Biotech Co., LTD, P.R. China |
XHLO |
20201102 |
RTK Antigen |
Nasopharyngeal or oropharyngeal swab samples |
|
19 |
Kaspur Medical Supplies (M) Sdn Bhd |
Jinwofu Novel Coronavirus (SARS-CoV-2) Antigen Rapid Test Kit Lot #: 20201102 |
Beijing Jinwofu Bioengineering Technology Co.,Ltd. P.R China. |
C3042 |
20201102 |
RTK Antigen |
Nasopharyngeal or oropharyngeal swab samples |
|
20 |
Medicara Sdn Bhd |
Jinwofu Novel Coronavirus (SARS-CoV-2) Antigen Rapid Test Kit Lot #: 20201102 |
Beijing Jinwofu Bioengineering Technology Co.,Ltd. P.R China. |
C3042 |
20201102 |
RTK Antigen |
Nasopharyngeal or oropharyngeal swab samples |
|
21 |
Azion Healthcare Sdn Bhd |
Jinwofu Novel Coronavirus (SARS-CoV-2) Antigen Rapid |
Beijing Jinwofu Bioengineering Technology Co.,Ltd. P.R China. |
C3042 |
E20210302 |
RTK Antigen |
Nasopharyngeal or oropharyngeal swab samples |
|
22 |
Trust Diagnostics Sdn Bhd |
LEPU SARS-CoV-2 Antigen Detection Kit (Colloidal Gold Immunochromatography) |
Beijing Lepu Medical Technology Co., Ltd. P.R. China |
N/A |
20CG2715X |
RTK Antigen |
Nasopharyngeal or oropharyngeal swab samples |
|
23 |
TEDA Wellness Solutions Sdn Bhd |
Lyher Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold) |
Hangzhou Laihe Biotech Co., Ltd. P.R. China |
LYHER AG RTK |
2011047 |
RTK Antigen |
Nasopharyngeal or oropharyngeal swab samples |
|
24 |
Brighton Occuhealth Services Sdn Bhd |
FASTEP Covid-19 Antigen Rapid Test Device |
Assure Tech (Hangzhou) Co. Ltd., Zhejiang, P.R. China |
COV-S23 |
SR2020012028 |
RTK Antigen |
Nasopharyngeal or oropharyngeal swab samples |
|
25 |
Translab (M) Sdn Bhd |
Helix i-SARS-CoV-2 Ag Rapid Test |
Cellex, Inc. 76 TQ Durham NC USA |
i-101 |
20201102 |
RTK Antigen |
Nasopharyngeal or oropharyngeal swab samples |
|
26 |
Top Biotech Sdn Bhd |
TOP RAPID COVID-19 Rapid Antigen Test Kit |
Top Biotech Sdn Bhd Subang Jaya, Selangor, |
Premium model (with accessory) Base model (without accessory) |
TBCV030021025 |
RTK Antigen |
Nasopharyngeal or oropharyngeal swab samples |
|
27 |
Tri-G Technologies Sdn Bhd |
RightSign SARS-CoV-2 Antigen Rapid Test Cassette |
Hangzhou Biotest Biotech Co. Ltd., Hangzhou, China |
INCP-C81 |
COVG2102009-S |
RTK Antigen |
Nasopharyngeal or oropharyngeal swab samples |
|
28 |
MyVantros Sdn Bhd |
Coronavirus Ag Rapid Test Cassette (Swab) |
Zhejiang Orient Gene Biotech Co., Ltd., Zhejiang, China |
N/A |
2011036 |
RTK Antigen |
Nasopharyngeal or oropharyngeal swab samples |
|
29 |
VQUEST Sdn Bhd |
SARS-CoV-2 Antigen Test kit |
Shenzhen Ultra-Diagnostics Biotec. Co., Ltd. P.R.China |
SC0202 |
20122101 |
RTK Antigen |
Nasopharyngeal or oropharyngeal swab samples |
|
30 |
Hyperion Sdn Bhd |
NATEJAH COVID-19 Antigen Rapid Test (Swab) |
Lana Al Khaleej Al Awal Factory for Medical Supplies Second Industrial City, Kingdom of Saudi Arabia |
LA24-1002 |
Sample |
RTK Antigen |
Nasopharyngeal or oropharyngeal swab samples |
|
31 |
Translab (M) Sdn Bhd |
NADAL® COVID-19 Ag Test (test cassette) |
nal von minden GmbH Germany |
243103N-20 |
175202 |
RTK Antigen |
Nasopharyngeal or oropharyngeal swab samples |
|
32 |
HWGB Medical Devices & Supplies Sdn Bhd |
SARS-CoV-2 Antigen Detection Kit (Colloidal Gold Method) |
Wenzhou OJA Biotechnology Co., Ltd. P.R China |
N/A |
ZKHT21020201 |
RTK Antigen |
Nasopharyngeal or oropharyngeal swab samples |
|
33 |
JKS Biomedical |
Getein Biotech GP One Step Test For Sars-Cov-2 Antigen (Colloidal Gold) |
Getein Biotech, Inc Nanjing, China |
CG2061 |
6SC210007WF1 |
RTK Antigen |
Nasopharyngeal or oropharyngeal swab samples |
|
34 |
Jingga Anggun Sdn Bhd |
Longsee 2019-nCoV Ag & Influenza A/B Ag Rapid Co-Detection Kit |
Guangdong Longsee Biomedical Co.,Ltd Guangzhou, P.R. China |
LS-C-T-005 |
CT005201205 |
RTK Antigen |
Nasopharyngeal or oropharyngeal swab samples |
|
35 |
ER Medicare |
Hotgen Novel Coronavirus 2019-nCoVAntigen Test (Colloidal Gold) |
Beijing Hotgen Biotech Co., Ltd. Beijing, P.R. China. |
688068.SH |
W2020113900 |
RTK Antigen |
Nasopharyngeal or oropharyngeal swab samples |
|
36 |
Interscience Sdn Bhd |
StrongStep SARS-CoV-2 Antigen Rapid Test |
Nanjing Liming Bio-products Co. Ltd. Jiangsu P.R. China |
500200 |
2011012 |
RTK Antigen |
Nasopharyngeal or oropharyngeal swab samples |
|
37 |
Almedico Sdn Bhd |
LabGun™ COVID-19 Rapid Antigen Kit |
CALTH Inc. |
CHR11L |
EX-CHR11L-2006 |
RTK Antigen |
Nasopharyngeal or oropharyngeal swab samples |
|
38 |
DiagnostiCARE Sdn Bhd |
Lifotronic SARS-CoV-2 Antigen (GICA) |
Shenzhen Lifotronic Technology Co., Ltd.,P.R. China |
320300102 |
YF8520004 |
RTK Antigen |
Nasopharyngeal or oropharyngeal swab samples |
|
39 |
Biomarketing Services (M) Sdn Bhd |
Lifotronic SARS-CoV-2 Antigen (GICA) |
Shenzhen Lifotronic Technology Co., Ltd. P.R. China |
320300102 |
SAR2101500 |
RTK Antigen |
Nasopharyngeal or oropharyngeal swab samples |
|
40 |
SPD Scientific (M) Sdn Bhd |
Innova SARS-CoV-2 Antigen Rapid Qualitative Test |
Innova Medical Group, Inc., USA |
BT 1309 |
X2101038 |
RTK Antigen |
Nasal or throat swab |
|
41 |
MY Big Sdn Bhd |
GeneFinder™ COVID-19 Ag Rapid Test |
OSANG Healtcare Co., Ltd, Gyeonggi-do, Korea |
INFI01ACA |
SN-2012-01 |
RTK Antigen |
Nasopharyngeal or oropharyngeal swab samples |
|
42 |
Siemens Healthcare Sdn Bhd |
CLINITEST Rapid COVID-19 Antigen Test |
Healgen Scientific Limited Liability Company., Houston USA. |
11555845 |
2010189 |
RTK Antigen |
Nasopharyngeal or oropharyngeal swab samples |
|
43 |
ACCOBIOTECH Sdn Bhd |
ACCO COVID-19 Ag |
ACCOBIOTECH Sdn Bhd, Johor, Malaysia |
ACCOVAG125 |
FMFPO 2201 |
RTK Antigen |
Nasopharyngeal or oropharyngeal swab samples |
|
44 |
Silver State Laboratory Sdn Bhd |
COVID-19 ANTIGEN RAPID TEST (Colloidal Gold) |
Joinstar Biomedical Technology Co Ltd Hangzhou, China. |
FGCOVG1300 |
CAG2103008G |
RTK Antigen |
Nasopharyngeal or oropharyngeal swab samples |
|
45 |
Bioworld Technologies Sdn Bhd |
GENEDIA W COVID-19 Ag |
Green Cross Medical Science Corp. |
643G |
643G2012 |
RTK Antigen |
Nasopharyngeal or oropharyngeal swab samples |
|
46 |
Dewina Consult Sdn |
Newgene Bioengineering COVID-19 Antigen Detection Kit |
New Gene (Hangzhou) Bioengineering Co.,Ltd.,China. |
Covid-19-NG08 |
20210228-01 |
RTK Antigen |
Deep throat saliva (DTS) |
|
47 |
Exza Medical Sdn Bhd |
Medomics SARS-CoV-2 Antigen Test Kit (LFIA) |
Jiangsu Medomics Medical Technology Co., Ltd., Jiangsu, China |
N/A |
2021012907 |
RTK Antigen |
Nasopharyngeal swabs or oropharyngeal swabs |
|
48 |
Holista Biotech Sdn Bhd |
Hecin 2019-nCoV Antigen Test Kit (colloidal gold method) |
Guangdong Hecin Scientific, Inc.,China |
2019-nCoV Antigen test kit (Colloidal gold method) |
20210313 |
RTK Antigen |
Nasopharyngeal swabs or oropharyngeal swabs |
|
49 |
VQM Marketing Sdn Bhd |
Alltest COVID-19 Antigen Rapid Test (Nasopharyngeal Swab) |
Hangzhou Alltest Biotech Co., Ltd., Hangzhou, China |
ICoV-502 |
ATCOV21010138 |
RTK Antigen |
Nasopharyngeal swabs or oropharyngeal swabs |
|
50 |
Neopharma Biotech Asia Sdn Bhd |
AllCheck COVID19 Ag Kit |
CALTH Inc. |
CHR11 |
CHR11cF2103 |
RTK Antigen |
Nasopharyngeal swabs |
|
51 |
Medcos International |
Asan Easy Test COVID-19 Ag |
Asan Pharmaceutical Co.,Ltd Gyeonggi-do, Korea |
AM3474-K (20T) AM3476-K (25T) |
EKF002c |
RTK Antigen |
Nasopharyngeal swabs and oropharyngeal swabs |
|
52 |
Tradebiz Marketing Sdn Bhd |
InstantSure Covid-19 Ag CARD |
Suzhou Soochow University Saier Immuno Biotech Co., Ltd |
InstantSure Covid-19 Ag CARD |
20210204 |
RTK Antigen |
Nasopharyngeal swabs and oropharyngeal swabs |
|
53 |
Instrumatrix Technology Sdn Bhd |
NOVA Test SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography) |
Atlas Link Technology Co., Ltd, People's Republic of China |
nCoV-500 |
202110305 |
RTK Antigen |
Nasopharyngeal swab & Oropharyngeal swabs |
|
54 |
BMS Diagnostics (M) Sdn Bhd |
Kaibili™ Covid-19 Antigen |
Hangzhou Genesis Biodetection & Biocontrol Co., Ltd. |
P211134 |
GP210101P |
RTK Antigen |
Nasopharyngeal swab or Oropharyngeal swabs |
|
55 |
BMS Diagnostics (M) Sdn Bhd |
Kaibili™ Covid-19 Antigen Neo |
Hangzhou Genesis Biodetection & Biocontrol Co., Ltd. |
P211136 |
GP210301P |
RTK Antigen |
Nasopharyngeal swab or Oropharyngeal swabs |
|
56 |
NeoScience Sdn Bhd |
Standard Q COVID-19 Ag Saliva Test |
SD Biosensor Inc, Korea |
REF: Q-NCOV-02G Catalog no. 09COV90D |
QC09020006 |
RTK Antigen |
Deep throat saliva |
|
57 |
Medinics (M) Sdn Bhd |
VivaDiag™ SARS-CoV-2 Ag Saliva Rapid Test |
VivaCheck Biotech (Hangzhou) Co., Ltd |
VCD17-01-012 |
SE2103027 |
RTK Antigen |
Saliva |
|
58 |
Pharmaniaga Marketing Sdn Bhd |
VivaDiag™ SARS-CoV-2 Ag Saliva Rapid Test |
VivaCheck Biotech (Hangzhou) Co., Ltd |
VCD17 |
SE2102094 |
RTK Antigen |
Saliva |
|
59 |
Pharmaniaga Marketing Sdn Bhd |
VivaDiag™ Pro SARS-CoV-2 Ag Rapid Test |
VivaCheck Biotech (Hangzhou) Co., Ltd |
VivaDiag |
SE2103063 |
RTK Antigen |
Nasopharyngeal swab or Oropharyngeal swabs |
|
60 |
VQM Marketing Sdn Bhd |
ALLTEST COVID-19 Antigen Rapid Test (Oral Fluid) |
Hangzhou AllTest Biotech Co., Ltd |
ICOV-802 |
ATCOV2103212-S |
RTK Antigen |
Saliva |
|
61 |
Teda Wellness Solutions Sdn Bhd |
Lyher® Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold) |
Hangzhou Laihe Biotech Co. Ltd Zhejiang, People's Republic of China |
303034 |
2103063 |
RTK Antigen |
Nasopharyngeal swab & Oropharyngeal swab |
|
62 |
HS Bio Supplies Sdn Bhd |
Realy Tech Novel Coronavirus (SARS-CoV-2) Antigen Rapid Test Cassette (swab) |
Hangzhou Realy Tech Co., Ltd |
K511416D |
202104032 |
RTK Antigen |
Nasopharyngeal swab & Oropharyngeal swab |
|
63 |
Medical Innovation Ventures Sdn Bhd |
ProDetect® COVID-19 Antigen Rapid Test (Oral Fluid) |
Medical Innovation Ventures Sdn Bhd |
PR-CVDCAgO |
PRCVDCAgO21MAY25 |
RTK Antigen |
Oral fluid |
|
64 |
Malaysian Diagnostics Corporation Sdn Bhd |
ZYBIO SARS-CoV-2 Antigen assay Kit (Colloidal Gold) |
Zybio Inc, Chongqing, China. |
2061701 |
510410 |
RTK Antigen |
Nasopharyngeal swab & Oropharyngeal swab |
|
65 |
Unimed Sdn Bhd |
Sensing Self S1 COVID19 Rapid Antigen Test Kit |
Sensing Self Pte. Ltd. Singapore |
ERCSSO5320 |
SS101027 |
RTK Antigen |
Nasopharyngeal swab & Oropharyngeal swab |
|
66 |
Chemopharm Sdn Bhd |
PCL COVID-19 Ag Gold |
PCL, Inc., Korea |
COV04S |
2105S811 |
RTK Antigen |
Saliva |
|
67 |
Chemopharm Sdn Bhd |
PCL COVID-19 Ag Gold |
PCL, Inc., Korea |
COV04S |
2105S811 |
RTK Antigen |
Nasal swab |
|
68 |
Chemopharm Sdn Bhd |
PCL COVID-19 Ag Gold |
PCL, Inc., Korea |
COV04S |
2105S811 |
RTK Antigen |
Nasopharyngeal swab |
|
69 |
Suria Medik Sdn Bhd |
Artron COViID-19 Antigen Test |
Artron Laboratories Inc., Canada. |
A03-50-422 |
6-210610 |
RTK Antigen |
Nasopharyngeal swab (NPS) |
|
70 |
Hygeia Instrum ents (Malaysia) Sdn Bhd |
NEWGENE Bioengineering COVID-19 Antigen Detection Kit |
New Gene (Hangzhou) Bioengineering Co., Ltd. |
Covid-19-NG08 |
20210228-01 |
RTK Antigen |
Deep throat saliva (DTS) |
|
71 |
Hygeia Instruments (Malaysia) Sdn Bhd |
NEWGENE Bioengineering COVID-19 Antigen Detection Kit |
New Gene (Hangzhou) Bioengineering Co., Ltd. |
Covid-19-NG08 |
20210228-01 |
RTK Antigen |
Nasopharyngeal Swab |
|
72 |
Prova Lab & Research Sdn Bhd |
Well Biotech COVID-19 Ag Rapid Saliva Test Device |
Jiangsu Well Biotech Co., Ltd. China. |
CO-03 |
202105181 |
RTK Antigen |
Saliva |
|
73 |
Neoscience Sdn Bhd |
STANDARD™ Q COVID-19 Ag Test |
SD Biosensor, Inc., Korea |
09COV31D, 09COV33D |
QC03120001A |
RTK Antigen |
Nasopharyngeal Swab (NPS) |
|
74 |
Neoscience Sdn Bhd |
STANDARD™ Q COVID-19 Ag Test |
SD Biosensor, Inc., Korea |
09COV31D, 09COV33D |
QC03120001A |
RTK Antigen |
Nasal Swab |
|
75 |
Abbott Diagnostics Health Sdn Bhd |
Panbio™ COVID-19 Ag Rapid Test Device (NASAL) |
Abbott Rapid Diagnostics Jena GmBH, Jena, Germany |
41FK11 |
41ADG260B, 41ADF45OA |
RTK Antigen |
Nasal swab |
|
76 |
AMD Solutions Sdn Bhd |
Boson Biotech Rapid SARS-CoV-2 Ag Test Card |
Xiamen Boson Biotech Co. Ltd., Xiamen, Fujian, P.R. China. |
1N40C5 |
21040103 |
RTK Antigen |
Nasal swab |
|
77 |
Jingga Anggun Sdn Bhd |
Longsee 2019-nCoV Ag & Influenza A/B Rapid Co-Detection Kit (immuno-chromatography) |
Guangdong Longsee Biomedical Co. Ltd., Guangzhou, China |
LS-C-T-005 |
CT005210531 |
RTK Antigen |
Saliva |
|
78 |
Infitos Sdn Bhd |
JINJIAN SARS-CoV-2 Antigen Test Kit (Colloidal Gold Method) |
Hubei JinJian Biology Co., Ltd., China. |
SARS-CoV-2-Ag02 |
210404 |
RTK Antigen |
Nasopharyngeal swab (NPS) |
|
79 |
Everest Medical Resources (M) Sdn Bhd |
VivaDiag™ SARS-CoV-2 Ag Saliva Rapid Test |
VivaCheck Biotech (Hangzhou) Co., Ltd. |
VCD17-01-012 |
SE2103162 |
RTK Antigen |
Saliva |
|
80 |
Nano Medic Care Sdn Bhd |
Flowflex™ SARS-CoV-2 Antigen Rapid Test |
ACON Biotech (Hangzhou) Co. Ltd., P.R. China |
L031-11825 |
20201028 |
RTK Antigen |
Nasal swab |
|
81 |
APSN Healthcare & Diagnostics Sdn Bhd |
CiTest COVID-19 Antigen Rapid Test (Oral fluid) |
CiTest Diagnostics Inc, Vancouver, Canada |
INCP-CT802 |
COV21060055 |
RTK Antigen |
Saliva |
|
82 |
WFR Medical Supplies Sdn Bhd |
WFR COVID-2019 Antigen Rapid Test Kit |
WFR Medical Supplies Sdn BHd. Pulau Pinang, Malaysia. |
WFR COVID-2019 Antigen Rapid Test Kit |
2021061504 |
RTK Antigen |
Nasopharyngeal swab (NPS) and Oropharyngeal swab (OPS) |
|
83 |
Impian Orto Medik Sdn Bhd |
JOYSBIO SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) |
JOYSBIO (Tianjin) Biotechnology Co, Ltd., Tianjin, China. |
G10314 |
2021022609 |
RTK Antigen |
Saliva |
|
84 |
Xinnerg Sdn Bhd |
ACRO COVID-19 Antigen Rapid Test (Oral Fluid) |
ACRO Biotech Inc |
INCP-AC0802 |
COV21060052ACO |
RTK Antigen |
Saliva |
|
85 |
Innovita Sdn Bhd |
Wuhan EasyDiagnosis COVID-19 Ag Test Kit |
Wuhan EasyDiagnosis Biomedicine Co., Ltd. |
W-Ag03-20 |
21040101 |
RTK Antigen |
Nasopharyngeal swab (NPS) or Oropharyngeal swab (OPS) |
|
86 |
City Medic Sdn Bhd |
Gmate® COVID-19 Ag Saliva (Professional) |
Philosys Co., Ltd. |
AG-019 |
CA10U800 |
RTK Antigen |
Saliva |
|
87 |
Tri-G Technologies Sdn Bhd |
DEEPBLUE COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold) Saliva |
Anhui Deepblue Medical Technology Co., Ltd, China. |
SL030101 |
20210302 |
RTK Antigen |
Saliva |
|
88 |
Brighton Occuhealth Services Sdn Bhd |
Dia Sure COVID-19 Antigen Rapid Test Device |
Azure Biotech Inc., USA |
COV-S23 |
SR2021050036 |
RTK Antigen |
Nasopharyngeal/ oropharyngeal swab (NPS/OPS) |
|
89 |
TS Diagnostics Sdn Bhd |
Forsure COVID-19 Antigen Rapid Test Kit (Oral Fluid) |
TS Diagnostics Sdn Bhd, Taman Perindustrian Puchong, Selangor, Malaysia. |
FS-CV190F-C30 |
21060053 |
RTK Antigen |
Saliva |
|
90 |
LabIVF (M) Sdn Bhd |
PCL COVID-19 Ag Gold |
PCL, Inc., Korea |
COV04S |
21025703 |
RTK Antigen |
1. Nasopharyngeal swab (NPS) |
|
91 |
Excel Med Sdn Bhd |
SARS-CoV-2 Antigen Detection KIt (Colloidal Gold Method) |
Xiamen Jiqing Biomedical Technology Co., Ltd., China. |
WKI0014 |
RI21G15CJQ |
RTK Antigen |
Nasal swab |
|
92 |
Medical Innovation Ventures Sdn Bhd |
Finecare™ 2019-nCoV Antigen Test |
Guangzhou Wondfo Biotech Co. Ltd., China |
W286 |
F28615108A |
RTK Antigen |
Nasopharyngeal/ Oropharyngeal swab |
|
93 |
Epsilon Medical Devices Sdn Bhd |
Virusee® SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) |
Genobio Pharmaceutical Co., Ltd, China |
VSLFA-20 |
VS210501 |
RTK Antigen |
Nasopharyngeal swab/ oropharyngeal swab (NPS/OPS) |
|
94 |
Vitramed (Asia) Sdn Bhd |
H&W COVID-19 Salivary Antigen Rapid Test Kit |
H & W Biotech Oy, Finland |
KSHW2003 |
S2321033001 |
RTK Antigen |
Saliva |
|
95 |
Dedikasi Semangat Sdn Bhd |
GenSure COVID-19 Antigen Rapid Test Kit (Swab) |
Gensure Biotech Inc., |
N/A |
P202105036 |
RTK Antigen |
Nasal swab |
|
96 |
Teda wellness Solutions Sdn Bhd |
LYHER® Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold) |
Hangzhou Laihe Biotech Co. Ltd |
303034 |
2106041 |
RTK Antigen |
Saliva |
|
97 |
Interscience Sdn Bhd |
StrongStep® SARS-CoV-2 Antigen Rapid Test |
Nanjing Liming Bio-Products Co. Ltd., P.R.China. |
500200 |
2107006 |
RTK Antigen |
Nasal swab, Saliva |
|
98 |
Cipla Malaysia Sdn Bhd |
Sure Status COVID-19 Antigen Test Card |
Premier Medical Corporation Private Limited |
SS03- Rapid Diagnostics Test |
9FE0521S |
RTK Antigen |
Nasopharyngeal swab (NPS) |
|
99 |
Qiagen Biotechnology (M) Sdn Bhd |
mö-screen Corona Antigen Test |
möLab GmbH, Langenfeld, Germany |
230005 |
2012610 |
RTK Antigen |
Nasal swab, nasopharyngeal swab/ oropharyngeal swab |
|
100 |
CLA Medical Sdn Bhd |
ONE STEP FOR SARS-CoV-2 Antigen (Colloidal Gold) Saliva |
Getein Biotech Inc. China |
CG2061 |
6SC216003W |
RTK Antigen |
Saliva |
|
101 |
Maximsuria sdn Bhd |
COVID-19 Salivary Antigen Rapid Test Kit |
WFR Medical Supplies Sdn Bhd |
N/A |
2021071604 |
RTK Antigen |
Saliva |
|
102 |
Advance Diagnostic Care Sdn Bhd |
SALIVA SARS-CoV (2019-nCoV) Antigen Test Kit (Nanocarbon Assay) |
Jiaxing Wisetest Bio-Tech Co. Ltd |
WT-1120 |
2021051801 |
RTK Antigen |
Saliva |
|
103 |
BA LALAJI Sdn Bhd |
Alpine Biomedicals One- Step CoVID- 19 Antigen Rapid Test |
Alphine Biomedicals Pvt. Ltd. Haryana, India |
N/A |
LCOVG-070521 |
RTK Antigen |
Nasal swab |
|
104 |
Veritas Medical Sdn Bhd |
DIAGNOS COVID-19 Antigen Saliva Test Kit (Colloidal Gold) |
Nantong Diagnos Biotechnology Co. Ltd, Jiangsu, P.R. China |
N/A |
202103011 |
RTK Antigen |
Saliva |
|
105 |
Teda Wellness Solutions Sdn Bhd |
LionRun™ SARS-CoV-2 Antigen Rapid Test (Lateral Flow Immunoassay) |
Shanghai Liangrun Biomedicine Technology Co., Ltd., Shanghai China. |
N/A |
X20210406 |
RTK Antigen |
Nasal swab (NS) |
|
106 |
SPD Scientific (M) Sdn Bhd |
Dynamiker SARS-CoV-2 Ag Rapid Test (Saliva) |
Dynamiker Biotechnology (Tianjin) Co., Ltd |
DNK-2105-1 |
210710-HW |
RTK Antigen |
Saliva |
|
107 |
Hygeia Instruments (M) Sdn Bhd |
CLUNGENE® COVID-19 Antigen Rapid Test Cassette |
Hangzhou Clongene Biotech. Co. Ltd., China. |
ICOV5002-100569/ICOV5002-100596 |
S202107056 |
RTK Antigen |
Nasal swab |
|
108 |
Nano Life Quest Sdn Bhd. |
Bioteke SARS-CoV-2 Antigen Test Kit (Colloidal Gold Method) |
BIOTEKE CORPORATION (WUXI) CO. LTD. |
Bioteke SARS-CoV-2 Antigen Test Kit |
TC10022021J0425 |
RTK Antigen |
Saliva |
|
109 |
N.A.Z. Medical Supplies Sdn Bhd |
SARS-CoV-2 Antigen Rapid Test (Nasal Swab) |
Hangzhou AllTest Biotech Co., Ltd., China |
INCP-502-N |
ATNCP2060037 |
RTK Antigen |
Nasal swab (NS) |
|
110 |
Translab (M) Sdn Bhd |
Flowflex SARS-CoV-2 Antigen Rapid Test (Nasal/Saliva) |
ACON Biotech (Hangzhou) Co., Ltd., China |
L031-12515 |
COV1080048 |
RTK Antigen |
Nasal swab (NS) |
|
111 |
Symbion Asia Sdn Bhd |
iHealth Novel Coronavirus Antigen Rapid Test Kit (Saliva) |
Symbion Asia Sdn Bhd |
Novel Coronavirus Antigen Rapid Test |
202108078 |
RTK Antigen |
Saliva |
|
112 |
Medispec (M) Sdn Bhd |
SARS-CoV-2 Antigen Saliva Rapid Test |
Qingdao Hightop Biotech Co., Ltd. China |
H100S |
COV-120818 |
RTK Antigen |
Saliva |
|
113 |
Robopreneur Sdn Bhd |
DIANOBIO Detection Kit for Antigen to SARS-CoV-2 (Colloidal Gold Immunochromatography Method) |
Shandong Diano Bio-tech Co., Ltd., China. |
DN-JJ-005 |
20210601 |
RTK Antigen |
Nasal swab (NS) |
|
114 |
Viga Gemilang Enterprise |
Goldsite SARS-CoV-2 Antigen KIt |
Goldsite Diagnostic Inc. China. |
CG123025 |
20210415 |
RTK Antigen |
Nasal Swab |
|
115 |
Axisbio Diagnostics Sdn Bhd |
QuickVue® SARS Antigen Test |
Quidel Corporation, San Diego, CA,USA |
20387 |
706702 |
RTK Antigen |
Nasal swab |
|
116 |
LABIVF (M) Sdn Bhd. |
RAPIGEN BIOCREDIT COVID-19 Ag One Step SARS-CoV-2 Antigen Rapid Test |
Rapigen, INC. |
G61RHA20 |
H073A023DA |
RTK Antigen |
Nasopharyngeal & Oropharyngeal swab |
|
117 |
Holista Biotech Sdn Bhd |
GeneSign 2019-nCoV Antigen Testing Kit |
GeneSign Biotech (Xiamen) Co. Ltd., China. |
Not available |
2021061601 |
RTK Antigen |
Nasopharyngeal & Oropharyngeal swab |
|
118 |
CLA Medical Sdn Bhd |
Getein Biotech One Step Test for SARS-CoV-2 Antigen |
Getein Biotech Inc., Nanjing, China. |
CG2061 |
6SC216014W |
RTK Antigen |
Nasal swab |
|
119 |
Genomax Technologies Sdn Bhd |
InstaView COVID-19 Antigen |
SG Medical Inc., Republic of Korea |
R3002 |
1CCOAG1H02 |
RTK Antigen |
Nasopharyngeal swab/ oropharyngeal |
|
120 |
SPD Scientific (M) Sdn. Bhd. |
DYNAMIKER SARS-CoV-2 AG RAPID TEST |
Dynamiker Biotechnology (Tianjin) Co., Ltd. |
DNK-1425-1 |
210705-HW |
RTK Antigen |
Nasopharyngeal / Oropharyngeal swab |
|
121 |
Aztec Scientific Sdn. Bhd. |
Vazyme SARS-CoV-2 Antigen Detection Kit (Colloidal Gold-Based) |
Nanjing Vazyme Medical Technology Co., Ltd. |
C8602C |
V2021010457C |
RTK Antigen |
Nasal swab |
|
122 |
Zuellig Pharma Sdn Bhd |
Hopegen COVID-19 Antigen Rapid Test Kit (Colloidal Gold) |
Xiamen Hopegen Medical Technology Co., Ltd. |
n/a |
220210402 |
RTK Antigen |
Nasal swab |
|
123 |
Karl Mueller Scientific Sdn Bhd |
2019-nCoV Ag Saliva Rapid Test Card |
Guangzhou Decheng Biotechnology Co., Ltd. |
0589C4X020 |
05821026C |
RTK Antigen |
Saliva |
|
124 |
Advance Diagnostic Care Sdn Bhd |
SARS-CoV-2 Antigen Test Kit (Colloidal Gold) |
Genrui Biotech Inc. |
Nasal swab: 52026094 |
Nasal swab: 20210813 |
RTK Antigen |
Nasal and Saliva |
|
125 |
Apace Medi Health Sdn Bhd |
Realy Novel Coronavirus (SARS-CoV-2) Antigen Rapid Test Device (Saliva) |
Hangzhou Realy Tech Co., Ltd., P.R. China. |
K590516D |
202108002 |
RTK Antigen |
Saliva |
|
126 |
JKS Biomedical Sdn Bhd |
Tigsun COVID-19 Saliva Antigen Rapid Test |
Bei Jing Tigsun Diagnostics Co., Ltd. China |
TG-1417 |
14172101 |
RTK Antigen |
Saliva |
|
127 |
Almedico Sdn Bhd |
StrongStep® SARS-CoV-2 Antigen Rapid Test |
Nanjing Liming Bio-Products Co., Ltd., P.R. China |
500200 |
2108001 |
RTK Antigen |
Saliva |
|
128 |
Chembio Diagnostics Malaysia Sdn Bhd |
DPP® SARS-CoV-2 Antigen Test for use with DPP Micro Reader and Micro Reader II |
Chembio Diagnostics Systems Inc |
65-9571-3; 65-9571-2 |
SCAG103120/A |
RTK Antigen |
Nasal swab |
|
129 |
Biotek Abadi Sdn Bhd |
COVID-19 Check-Sal Antigen Rapid Test |
Multi G bvba, Belgium |
MGGENSAL25 |
MGCGEN20210308 |
RTK Antigen |
Saliva |
|
130 |
Translab (M) Sdn Bhd |
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antigen Assay Kit by Colloidal Gold Method (MACCURA) |
Maccura Biotechnology Co., Ltd |
EIM4102081 |
521011 |
RTK Antigen |
Nasal swab |
|
131 |
Biomarketing Services (M) Sdn Bhd |
SARS-CoV-2 Antigen Rapid Detection Kit |
Shenzhen CAS-Envision Medical Technology Co., Ltd. China |
CG201A_HP |
P202109001 |
RTK Antigen |
Nasopharyngeal swab (NPS) or Oropharyngeal swab (OPS) |
|
132 |
LKL Advance Metaltech Sdn Bhd |
Medomics SARS-CoV-2 Antigen Test Kit (LFIA) |
Jiangsu Medomics Medical Technology Co., Ltd. |
SARS-CoV-2 antigen Test Kit (LFIA) 20test/box, 5test/box, 1test/box |
MKDS2021033101 |
RTK Antigen |
Nasal swab |
|
133 |
Axisbio Diagnostics Sdn Bhd |
JusChek™ SARS-CoV-2 Antigen Rapid Test (Nasal Swab) |
ACRO BIOTECH Inc. USA |
ISCO-ACO502 |
NCP21090099ACO |
RTK Antigen |
Nasal swab |
|
134 |
Chembio Diagnostics Malaysia Sdn Bhd |
DPP® SARS-CoV-2 Antigen |
Chembio Diagnostics Systems Inc. |
65-9572-0, 65-9572-1 |
SCAG111820/A |
RTK Antigen |
Nasal swab |
|
135 |
Pharmaniaga Marketing Sdn Bhd |
VivaDiag™ Pro SARS-CoV-2 Ag Rapid Test |
VivaCheck Biotech (Hangzhou) Co., Ltd. |
VCD16-01-011 |
SE2108077 |
RTK Antigen |
Nasal swab |
|
136 |
Daiichi Biotech Services Sdn Bhd |
Lifotronic SARS-CoV-2 Antigen (GICA) |
Shenzhen Lifotronic Technology Co., Ltd |
320300102 |
SAR2103980 |
RTK Antigen |
Nasal swab |
|
138 |
Axisbio Diagnostics Sdn Bhd |
JusChek™ COVID-19 Antigen Rapid Test (Oral Fluid) |
ACRO BIOTECH Inc. |
INCP-ACO802 |
COV21090219ACO |
RTK Antigen |
Saliva |
|
139 |
Alliance Integrity Trading Sdn Bhd |
Clungene® COVID-19 Antigen Rapid Test Cassette |
Hangzhou Clongene Biotech Co., Ltd. |
ICOV5002-100596 |
S202109020 |
RTK Antigen |
Nasopharyngeal swab (NPS) or Oropharyngeal swab (OPS) |
|
140 |
Starvilion Sdn Bhd |
COVID-19 Antigen Detection kit |
New Gene (Hangzhou) Bioengineering Co., Ltd. |
COVID-19-NG08 |
20210820-01 |
RTK Antigen |
Saliva |
|
141 |
Medisafe Technologies Sdn Bhd |
COVID-19 Ag Saliva HT |
WIZCHEM Co., Ltd. |
CAG301S |
CAGS-20210801 |
RTK Antigen |
Saliva |
|
142 |
Xinnerg Sdn Bhd |
COVID-19 Antigen Rapid Test (Oral Fluid) |
Hangzhou All Test Biotech Co., Ltd. |
ICOV-802 |
ATCOV21080188 |
RTK Antigen |
Saliva |
|
143 |
Nano Medic Care Sdn Bhd |
SEJOY SARS-CoV-2 Antigen Rapid Test Cassette |
Hangzhou Sejoy Electronic & Instruments Co., Ltd, China. |
COVG-602 |
COVG202109NMC |
RTK Antigen |
Nasal swab |
|
144 |
Daiichi Biotech Services Sdn Bhd |
GLINE-2019-nCoV Ag Test |
Shenzhen YHLO Biotech Co., Ltd. |
G86247 |
20210706 |
RTK Antigen |
Nasal swab |
|
NO |
COMPANY NAME |
PRODUCT NAME |
MANUFACTURER |
IDENTIFIER |
LOT NUMBER |
GENE |
DETECTION |
SAMPLE TYPE |
|
1 |
Qiagen Biotechnology Malaysia |
QIAstat-Dx Respiratory SARS-CoV-2 Panel |
Qiagen N.V Netherlands |
691214 |
N/A |
ORF1ab and E gene |
RT-PCR (POCT) |
Nasopharyngeal or oropharyngeal swab samples |
|
2 |
Translab (M) Sdn Bhd |
EasyNAT COVID-19 Nucleic Acid Detection Kit |
Ustar Biotechnologies (Hangzhou) Co., Ltd., P.R. China |
U30003 U20226 |
20200812 |
ORF1ab, N and E gene |
Rapid Isothermal Amplification (POCT) |
Nasopharyngeal or oropharyngeal swab samples |
|
3 |
SPD Scientific (M) Sdn Bhd |
Xpert Xpress SARS-CoV-2 |
Cepheid, 904 Caribbean Drive, Sunnyvale, CA, USA |
XPRSARS-COV2-10 |
N/A |
N and E gene |
RT-PCR (POCT) |
Nasopharyngeal or oropharyngeal swab samples |
|
4 |
Alere Health Sdn Bhd / Abbott Laboratories |
ID NOW Covid-19 Assay |
Abbott Diagnostics Scarborough, Inc., USA |
190-000 (ID Now Covid-19 Test Kit) |
190-001 & 190-002 |
RdRp gene |
RAPID ISOTHERMAL NEAR (Rapid Molecular) |
Nasopharyngeal or oropharyngeal swab samples |
|
5 |
Neoscience Sdn Bhd |
Sansure Biotech Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) |
Sansure Biotech Inc. P.R. China |
S3102E, |
2020116-3 |
ORF1ab and N gene |
RT-PCR (POCT) |
Nasopharyngeal or oropharyngeal swab samples |
|
6 |
Neopharma Biotech Asia Sdn Bhd |
AQ-TOP COVID-19 Rapid Detection Kit PLUS |
Seasun Biomaterials Inc. Republic of Korea. |
RT-LAMP |
CVPR201005 |
ORF1ab and, RNase P gene |
RT-LAMP (POCT) |
Nasopharyngeal or oropharyngeal swab samples |
|
7 |
Neopharma Biotech Asia Sdn Bhd |
Isopollo® COVID-19 Detection Kit (real-time) |
M monitor Inc. Republic of Korea |
52227 |
522279239 |
RdRp and N gene |
RT-LAMP (POCT) |
Nasopharyngeal or oropharyngeal swab samples |
|
8 |
Setanding Enterprise Sdn Bhd |
CELLSAFE LAMPlex™ RT-qLAMP COVID-19 Detection Assay |
CellSafe Co., Ltd. Republic of Korea |
CSCOLAN-100 |
COLA120120 |
N gene |
RT-qLAMP (Rapid Molecular) |
Nasopharyngeal or oropharyngeal swab samples |
|
9 |
DNA Laboratories Sdn Bhd |
Real-time fluorescent RT- PCR kit for detecting 2019- nCoV |
BGI Europe A/S Denmark |
MFG030015 |
67202101001 |
ORF1ab gene |
RT-PCR |
Nasopharyngeal or oropharyngeal swab samples |
|
10 |
Pantasniaga Sdn Bhd |
Real-time fluorescent RT-PCR kit for detecting 2019- nCoV |
BGI Europe A/S Denmark |
MFG030015 |
67202101001 |
ORF1ab gene |
RT-PCR |
Nasopharyngeal or oropharyngeal swab samples |
|
11 |
BioD Medica Sdn Bhd |
3DMed 2019-nCoVRT- qPCR Detection Kit |
3D Biomedicine Science & Technology Co., Ltd. P.R. China. |
3103010011 |
QP06200301E |
ORF1ab, E and N gene |
RT-PCR |
Nasopharyngeal or oropharyngeal swab samples |
|
12 |
Deena System Sdn Bhd |
STANDARD M nCoV Real-Time Detection Kit |
SD Biosensor Republic Of Korea |
M-NCOV-01 |
MNCO0120011 |
ORF1ab (RdRp) and E gene |
RT-PCR |
Nasopharyngeal or oropharyngeal swab samples |
|
13 |
Roche Diagnostics (M) Sdn Bhd |
cobas® SARS-CoV-2 cobas® SARS-CoV-2 Control Kit |
Roche Diagnostics GmbH Mannheim, Germany |
09175431190 |
G24743 |
ORF1ab and E gene |
RT-PCR |
Nasopharyngeal or oropharyngeal swab samples |
|
14 |
Duopharma (M) Sdn Bhd |
Real-Q 2019-nCoV Detection Kit |
BioSewoom Inc. Republic of Korea |
BS7nCoV |
580L-009 |
RdRp and E gene |
RT-PCR |
Nasopharyngeal or oropharyngeal swab samples |
|
15 |
ER Medicare |
Toneker Novel coronavirus (SARS-CoV-2) nucleic acid detection kit (PCR fluorescence method) |
Anhui Toneker Biotechnology Co., Ltd. P.R. China. |
N/A |
200506 |
ORF1ab and N gene |
RT-PCR |
Nasopharyngeal or oropharyngeal swab samples |
|
16 |
Green Health Global Sdn Bhd |
Real time RT PCR Detection Kit For 2019 nCoV |
Hangzhou DIAN Biotechnology Co Ltd. P.R. China |
N/A |
200427011 |
ORF1ab and E gene |
RT-PCR |
Nasopharyngeal or oropharyngeal swab samples |
|
17 |
Biomarketing Services (M) Sdn Bhd |
Liferiver Novel Coronavirus (2019-nCoV) Real Time Multiplex RT-PCR Kit |
Shanghai ZJ Bio-tech Co., Ltd. P.R. China. |
RR-0479-02 |
P20200401 |
ORF1ab, N and E gene |
RT-PCR |
Nasopharyngeal or oropharyngeal swab samples |
|
18 |
Medicara Sdn Bhd |
XABT Multiple Real-Time PCR Kit for Detection of 2019-nCoV |
Beijing Applied Biological Technologies Co., Ltd. P.R.China |
CT8223-48T |
20200403 |
ORF1ab, N and E gene |
RT-PCR |
Nasopharyngeal or oropharyngeal swab samples |
|
19 |
Emergo Malaysia Sdn Bhd |
AccuraDTectTM SARS- CoV-2 RT-qPCR Kit |
Genomictree Inc. Republic of Korea |
GT-CV2-100 |
GT-CV2-200402 |
N and RNase P gene |
RT-PCR |
Nasopharyngeal or oropharyngeal swab samples |
|
20 |
HWG Consortium Sdn Bhd |
eDiagnosis COVID-19 (SARS-CoV-2) Nucleic Acid Test Kit |
Wuhan EasyDiagnosis Biomedicine Co.,Ltd. P.R. China |
N/A |
200701HW |
ORF1ab and N gene |
RT-PCR |
Nasopharyngeal or oropharyngeal swab samples |
|
21 |
Premier Diagnostics Sdn. Bhd. |
eDiagnosis COVID-19 (SARS-CoV-2) Nucleic Acid Test Kit |
Wuhan EasyDiagnosis Biomedicine Co., Ltd. |
N/A |
200701HW |
ORF1ab and N gene |
RT-PCR |
Nasopharyngeal or oropharyngeal swab samples |
|
22 |
Klinik Kuchai (Dr Kaarthikk Gaanth A/L Kanniah) |
MoleculTech Real-Time COVID-19 |
YD Diagnostics Corp, |
N/A |
M2042011 |
RdRp and E gene |
RT-PCR |
Nasopharyngeal or oropharyngeal swab samples |
|
23 |
Biomerieux Malaysia Sdn Bhd |
BioFire RP 2.1 plus |
Biofire Defence, Utah, USA |
423740 |
LOT 1324720 |
S and M gene |
RT-PCR |
Nasopharyngeal or oropharyngeal swab samples |
|
24 |
Neoscience Sdn Bhd |
Allplex™ SARS-CoV-2 |
Seegene Inc, Republic of Korea |
RV10247Y & RV10248X |
N/A |
E, RdRP, S and N gene |
RT-PCR |
Nasopharyngeal or oropharyngeal swab samples |
|
25 |
Neoscience Sdn Bhd |
Allplex™ 2019-nCoV Assay |
Seegene Inc, Republic of Korea |
RP10244Y & RP10243X |
RP4520HC4 |
E, RdRP and N gene |
RT-PCR |
Nasopharyngeal or oropharyngeal swab samples |
|
26 |
Biomarketing Services (M) Sdn Bhd |
TaqPath™ COVID-19 CE-IVD RT-PCR Kit (Cat.No: A48067) |
Life Technologies Corporation CA, USA |
A48067 |
2003009 |
ORF1ab, S and N gene |
RT-PCR |
Nasopharyngeal or oropharyngeal swab samples |
|
27 |
Siemens Healthcare Sdn Bhd |
FTD SARS-CoV-2 |
Fast Track Diagnostics Germany |
REF: FTD-114-96 |
SC20-96-11 |
ORF1ab and N gene |
RT-PCR |
Nasopharyngeal or oropharyngeal swab samples |
|
28 |
Malaysian Diagnostics Corporation Sdn Bhd |
GeneFirst COVID-19 Nucleic Acid Diagnostic Kit |
GeneFirst Limited, United Kingdom |
COVID-19 |
100 |
ORF1ab and N gene |
RT-PCR |
Nasopharyngeal or oropharyngeal swab samples |
|
29 |
Biomarketing Services (M) Sdn Bhd |
TaqPath™ COVID-19 Combo Kit (Cat No.: A47814) |
Life Technologies Corporation, USA. |
A47814 |
2003009 |
ORF1ab, N and S gene |
RT-PCR |
Nasopharyngeal or oropharyngeal swab samples |
|
30 |
Interscience Sdn Bhd |
Viasure Sars-CoV-2 Real Time PCR Detection kit |
CerTest Biotec SL. Spain |
VS-NC0206L VS-NCO206H VS-NCO212L VS-NCO212H VS-NCO213L VS-NCO213H |
NCO212L-084 |
ORF1ab and N gene |
RT-PCR |
Nasopharyngeal or oropharyngeal swab samples |
|
31 |
Med Save Assistance Sdn Bhd |
Fosun 2019-nCoV qPCR |
Shanghai Fosun Long March Medical Science Co., Ltd. P.R. China |
N/A |
20200406 |
ORF1ab, N and E gene |
RT-PCR |
Nasopharyngeal or oropharyngeal swab samples |
|
32 |
Tri-G Technologies Sdn Bhd |
Fosun 2019-nCoV qPCR |
Shanghai Fosun Long March Medical Science Co., Ltd. |
PCSYHF02-a (48 tests/kit); PCSYHF03-a (96 tests/kit). |
20200414 |
ORF1ab, N and E gene |
RT-PCR |
Nasopharyngeal or oropharyngeal swab samples |
|
33 |
MPCN Dot Com Sdn Bhd |
Fosun 2019-nCoV qPCR |
Shanghai Fosun Long March Medical Science Co., Ltd. P.R. China |
N/A |
E20200415 |
ORF1ab, N and E gene |
RT-PCR |
Nasopharyngeal or oropharyngeal swab samples |
|
34 |
Premier Diagnostics Sdn Bhd |
LabGun COVID-19 RT- PCR Kit |
LabGenomics Co.,Ltd. Republic of Korea |
CV9032B |
CVR20E001 |
RdRp and E gene |
RT-PCR |
Nasopharyngeal or oropharyngeal swab samples |
|
35 |
Medical Innovations Ventures Sdn Bhd |
GenoAmp® Real-Time RT-PCR SARS-CoV-2 |
Medical Innovation Ventures Sdn. Bhd. Penang, Malaysia. |
GRA2033 |
GRA203320OCT06 |
RdRp, S and N gene |
RT-PCR |
Nasopharyngeal or oropharyngeal swab samples |
|
36 |
Neopharma Biotech Asia Sdn Bhd |
MolecuTech® Real-Time COVID-19 |
YD Diagnostics Corp. Republic of Korea |
MolecuTech® |
M2042011 |
RdRp and E gene |
RT-PCR |
Nasopharyngeal or oropharyngeal swab samples |
|
37 |
Key Alliance Sdn Bhd |
WellsBio CareGENE N- CoV RT-PCR kit |
Wells Bio, Inc Republic of Korea |
MCD-N05082 |
MNC20F291 |
RdRp and E gene |
RT-PCR |
Nasopharyngeal or oropharyngeal swab samples |
|
38 |
Translab (M) Sdn Bhd |
Maccura SARS-CoV-2 Fluorescent PCR |
Maccura Biotechnology Co. Ltd. P.R. China |
EGN7101109, EGN7103109 |
1020561 |
ORF1ab, E and N gene |
RT-PCR |
Nasopharyngeal or oropharyngeal swab samples |
|
39 |
My Big Sdn Bhd |
Genefinder Covid-19 Plus RealAmp Kit |
Osang Healthcare Co. Ltd. Republic of Korea |
IFMR-45 |
2003-R45-27 |
RdRP, E and N gene |
RT-PCR |
Nasopharyngeal or oropharyngeal swab samples |
|
40 |
Trust Diagnostics (M) Sdn Bhd |
GB SARS-CoV-2 Real- Time RT-PCR |
General Biologicals Corporation, Taiwan |
4PCO042E |
PVT60A07 |
ORF1ab and E gene |
RT-PCR |
Nasopharyngeal or oropharyngeal swab samples |
|
41 |
Ambang Sihat Sdn Bhd |
1copyTM COVID-19 qPCR Multi Kit |
1drop Inc. Republic of Korea |
M22MD100M |
M220K2400 |
E and RdRp gene |
RT-PCR |
Nasopharyngeal or oropharyngeal swab samples |
|
42 |
Axisbio Diagnostics Sdn Bhd |
Labsystems Diagnostics Covid-19 Real-Time PCR Kit |
Labsystems Diagnostics Oy Vantaa, Finland |
8100513 |
312RK1-1 |
ORF1ab, E and N gene |
RT-PCR |
Nasopharyngeal or oropharyngeal swab samples |
|
43 |
Medical Innovations Ventures Sdn Bhd |
GenoAmp® Real-Time RT-PCR Flu A/ Flu B/SARS-CoV-2/MERS-CoV |
Medical Innovation Ventures Sdn. Bhd. |
GRA2032 |
GRA203220DEC10 |
RdRp, S and N gene |
RT-PCR |
Nasopharyngeal or oropharyngeal swab samples |
|
44 |
Canvio Sdn Bhd |
iAMP® COVID-19 Detection Kit |
Atila BioSystems, Inc. CA, USA |
iAMP-COVID19-100 |
COVID20200506 |
ORF1ab and N gene |
RT-PCR |
Nasopharyngeal or oropharyngeal swab samples |
|
45 |
Interscience Sdn Bhd |
Alinity m SARS-CoV-2 AMP kit |
Abbott Molecular Inc. USA |
09N78-090, |
510732 |
RdRp and N gene |
RT-PCR |
Nasopharyngeal or oropharyngeal swab samples |
|
46 |
Medical Innovations Ventures Sdn Bhd |
RESOLUTE 2.0 SARS-CoV-2 Direct Detection Kit |
AMT Pte. Ltd. |
CKFG0002 |
CK02000026 |
E, N and RNase P gene |
RT-PCR |
Nasopharyngeal or oropharyngeal swab samples |
|
47 |
Science Vision Sdn Bhd |
AccuPower SARS-CoV-2 Multiplex Real-Time RT-PCR Kit |
Bioneer Corporation Republic of Korea |
SCVM-2112 |
200931L |
E, RdRp and N gene |
RT-PCR |
Nasopharyngeal or oropharyngeal swab samples |
|
48 |
Biomerieux Malaysia Sdn Bhd |
BioFire® Respiratory Panel 2.1 (RP2.1) |
Biofire Defence, USA |
423738 |
423738 |
S gene and M gene |
RT-PCR |
Nasopharyngeal or oropharyngeal swab samples |
|
49 |
ADT Biotech Sdn Bhd |
LyteStar™ 2019-nCoV PCR Kit 2.0 |
ADT Biotech Sdn Bhd, Malaysia |
888003 |
N/A |
E gene and RdRP gene |
RT-PCR |
Nasopharyngeal or oropharyngeal swab samples |
|
50 |
UAGB Biotech Sdn Bhd |
Vazyme 2019-Novel Coronavirus (2019-nCoV) Triplex RT-qPCR Detection Kit |
Nanjing Vazyme Medical Technology Co., Ltd. |
CD302 |
7E480J0 |
ORF1ab, N and RNase P gene |
RT-PCR |
Nasopharyngeal or oropharyngeal swab samples |
|
51 |
Pantasniaga Sdn Bhd |
Real-time Fluorescent RT-PCR Kit for Detecting SARS-CoV-2 |
BGI Europe A/S |
MFG030015 |
67202101001 |
ORF1ab, and N gene |
RT-PCR |
Nasopharyngeal or oropharyngeal swab samples |
|
52 |
SPD Scientific (M) Sdn Bhd |
Genedrive® 96 SARS-CoV-2 Kit |
Genedrive Diagnostics Ltd. 48 Grafton Street, Manchester M13 9XX United Kingdom |
D-COV2-01-LPC |
17161082BP |
E and N gene |
RT-PCR |
Nasopharyngeal or oropharyngeal swab samples |
|
53 |
Perkin Elmer Sdn Bhd |
PerkinElmer® 96 SARS-CoV-2 kit |
Suzhou SYM-BIO LifeScience Co.,Ltd. Jiangsu Province, China |
COVID-18-PCR-AUS-C |
AZ 20200812 |
ORF1ab gene |
RT-PCR |
Nasopharyngeal or oropharyngeal swab samples |
|
54 |
Wija Pharma Sdn Bhd |
Zybio SARS-CoV-2 Nucleic Acid Detection Kit (PCR-Fluorescent Probe Method) |
Zybio Inc. China |
CoV2-32 |
5102005 |
ORF1ab, and N gene |
RT-PCR |
Nasopharyngeal or oropharyngeal swab samples |
|
55 |
DW LABS Sdn Bhd |
Diagnovital SARS-CoV-2 Multiplex Real Time PCR |
RTA Laboratuvarlari Biyolojik Urunler |
09072025 09072050 09072100 |
CP2077221 |
N gene ORF1 ab gene, RNAse P |
RT-PCR |
Nasopharyngeal swabs or oropharyngeal swabs |
|
56 |
Almedico Sdn Bhd |
WizDx™ COVID-19 CrystalMix PCR Kit |
Wizbiosolutions Inc. South Korea |
DX1203A (96 Tests/kit), eQ162C (Portable PCR Machine) |
5B1220-01 |
RdRp and E gene |
RT-PCR |
Nasopharyngeal (NPS) combined with Oropharyngeal (OPS) swabs |
|
57 |
Health4u Solutions Sdn Bhd |
Oxsed RaViD Direct SARS-CoV-2 Test |
Oxford MEStar Ltd. Oxford, United Kingdom |
RaVID-OQ8 |
GD201028-T01 |
- |
RT-LAMP |
Nasopharyngeal swab & Oropharyngeal swabs |
|
58 |
Interscience Sdn Bhd |
VIASURE SARS-CoV-2, Flu & RSV Real Time PCR Detection Kit |
CerTest Biotec, S.L., Zaragoza, Spain |
VS-CFR112L |
CFR112L-005 |
N gene, RNAse P |
RT-PCR |
Nasopharyngeal swab & Oropharyngeal swabs |
|
59 |
Medical Innovation Ventures Sdn Bhd |
GenoAmp® Real-Time RT-PCR COVID-19 |
Medical Innovation Ventures Sdn Bhd., Penang, Malaysia |
Product code: GRA2035 |
GRA203521MAY03 |
RdRp gene, S gene, and N genes |
RT-PCR |
Nasopharyngeal swab & Oropharyngeal swabs |
|
60 |
Interscience Sdn Bhd |
Abbott RealTime SARS-CoV-2 Amplification Reagent KIt, Abbott RealTime SARS-CoV-2 Control Kit |
Abott Molecular INC, USA |
09N77-090, 09N77-080, 09N77-001 |
514504 |
RdRp gene, N gene |
RT-PCR |
Nasopharyngeal swab & Oropharyngeal swabs |
|
61 |
SPD Scientific (M) Sdn Bhd |
SARS-CoV-2 Elite MGB® Kit |
ElitechGrop S. p. A. C. so Torino, Italy |
RTS170ING |
U1020-070 |
RdRp gene, ORF8 gene |
RT-PCR |
Nasopharyngeal swab & Oropharyngeal swabs |
|
62 |
Trust Diagnostics Sdn Bhd |
SARS-CoV-2 Test Kit (Real-time PCR) Automatic Medical PCR Analysis System Sanity 2.0 |
Xiamen Zeesan Biotech Co., Ltd, China |
801305 (contains reagent for 12 tests) |
21022401 |
ORF1ab gene N gene RNase |
RT-PCR |
Nasopharyngeal swab & Oropharyngeal swabs |
|
63 |
Edaran Medicaltech (M) Sdn Bhd |
Ezplex SARS-CoV-2 G Kit |
SML Genetree Co, Ltd, Korea |
GNT2011-1 |
NCVA02EI002 |
RdRp gene N gene |
RT-PCR |
Nasopharyngeal swab & Oropharyngeal swab |
|
64 |
Neoscience Sdn Bhd |
Allplex™ SARS-CoV-2 Master Assay |
Seegene Inc, Republic of Korea |
RV10284X |
RVA321C01 |
E gene, RdRP gene, S gene, and N gene) and variants of S gene (HV69/70del, Y144del, E484K, N501Y, P681H) |
RT-PCR |
Extracted RNA from samples confirmed for COVID-19 and genotyped using gold standard whole genome sequencing |
|
65 |
Neoscience Sdn Bhd |
Allplex™ SARS-CoV-2 Variants I Assay |
Seegene Inc, Republic of Korea |
RV10286X, RV10287Y |
RVA521C01 |
Spike protein mutations(E484,N501Y, and HV69/70 deletion) and RdRP gene |
RT-PCR |
Extracted RNA from samples confirmed for COVID-19 and genotyped using gold standard whole genome sequencing |
|
66 |
Neoscience Sdn Bhd |
Allplex SARS-CoV-2/FluA/FluB/RSV Assay |
Seegene Inc, Republic of Korea |
RV10259X, RV10260Y |
RV19320J08 |
S gene, RdRp gene, N gene |
Multiplex real-time one-step RT-PCR |
RNA extracted material from nasopharyngeal swab(NPS) combined with Oropharyngeal swab (OPS) |
|
67 |
Numeric Diagnostics (M) Sdn Bhd |
MiRXES Fortitude SARS-CoV-2 and Flu A/B Test |
MiRXES Pte. Ltd. Singapore |
FGS0022R |
D14-21006 |
ORF1ab gene, N gene |
RT-PCR |
Nasopharyngeal swab & Oropharyngeal swab |
|
68 |
Hyperion Sdn Bhd |
TEPAT 1.0 SARS-CoV-2 Multiplex RT-PCR Kit |
CELLBAE PTE LTD, 31 Bioplolis Way The Nanos, Singapore. |
TP-001-01 |
P202009-C10 |
RdRp gene, M gene |
RT-PCR |
Nasopharyngeal swab(NPS) & Oropharyngeal swab (OPS) |
|
69 |
Pharmaniaga Marketing Sdn Bhd |
LANDWIND Novel Coronavirus (2019-nCoV) Nucleic acid Diagnostic Kit |
Shenzhen Landwind Biotechnology Co., Ltd., Guangdong Province. |
N/A |
192410002 |
ORF1ab gene, N gene |
PCR- Fluorescence Probing |
Nasopharyngeal swab(NPS) & Oropharyngeal swab (OPS) |
|
70 |
Next Gene Scientific Sdn Bhd |
abTES COVID-19 qPCR I Kit |
AITbiotech Pte Ltd 25, Pandan Crescent #05-15, TIC TECH Centre, Singapore 128477 |
#300141, #300142 #800811_C |
L141-261 |
Orf1a gene |
RT-PCR |
Oropharyngeal & nasopharyngeal swab |
|
71 |
Neoscience Sdn Bhd |
Allplex SARS-CoV-2 Assay (Extraction NIMBUS) |
Seegene Inc. Taewon Bldg., 91 Ogeum-ro, Songpa-gu, Seoul, Republic of Korea 05549 |
RV10247Y & RV10248X |
RV9121C22 |
Egene, RdRP gene, S gene, N gene |
RT-PCR |
Saliva |
|
72 |
BioD Medica Sdn Bhd |
ANDiS FAST SARS-CoV-2 RT-qPCR Detection Kit |
3D Biomedicine Science & Technology Co., Ltd. China. |
3103010069 |
QP08210401E1 |
ORF1ab gene, N gene, E gene |
RT-PCR |
Nasopharyngeal swab (NPS) and Oropharyngeal swab (OPS) |
|
73 |
Ewis Sdn Bhd |
Geneme® FRANKD SARS-CoV-2 Isothermal Amplification Detection Kit |
Geneme Sp. I ul, Poland. |
FRAND Sample Collection Kit (5373436448) |
88161120001 |
S gene |
RT-PCR |
Nasopharyngeal swab (NPS) and Oropharyngeal swab (OPS) |
|
74 |
My-Sutera Sdn Bhd |
GENEDIA W COVID-19 Real time RT-PCR |
Green Cross Medical Science Corp., Republic of Korea |
759A |
759A2003 |
RdRP, E,N,S gene |
RT-PCR |
Nasopharyngeal swab (NPS) and Oropharyngeal swab (OPS) |
|
75 |
Science Vision Sdn Bhd |
BioTNS COVID-19 RT-PCR PNA Kit |
BioTNS TNS Co. Ltd., Korea. |
TD1100 |
BCCA |
RdRp gene, N gene |
RT-PCR |
Nasopharyngeal swab (NPS) and Oropharyngeal swab (OPS) |
|
76 |
Neoscience Sdn Bhd |
Agilent SARS-CoV-2 qRT-PCR Dx Kit |
Agilent Technologies, Inc. 1834, Hwy 71 West Cedar Creek, TX 78612. USA. |
Catalogue No.: K1180A, K1180B, K1180C |
6609769 |
N1 gene and N2 gene |
RT-PCR |
Oropharyngeal and Nasopharyngeal swab |
|
77 |
Monitorbio Group Sdn Bhd |
LIUR Test Saliva- Based COVID-19 PCR Test |
MonitorBio Group Sdn Bhd |
LIUR |
MBG 2021005 |
N gene and S gene |
RT-PCR |
Saliva |
|
78 |
Tri-G Technologies Sdn Bhd |
LabGun™ COVID-19 Exofast RT-PCR Kit |
LabGenomics Co. Ltd., Republic of Korea. |
CV9034B |
CVF21E004 |
RdRp gene, N gene |
RT-PCR |
Oropharyngeal and Nasopharyngeal swab |
|
79 |
Qiagen Biotechnology Malaysia Sdn Bhd |
ARTUS® SARS-CoV-2 Prep&Amp |
Qiagen GmbH, Germany |
Reaction : |
169028102 |
N1 gene and N2 gene |
RT-PCR (POCT) |
1. Nasopharyngeal (NPS)/ Oropharyngeal swab (OPS) |
|
80 |
Matrioux (M) Sdn Bhd |
Novel Coronavirus (2019-nCoV) Real Time Multiplex RT-PCR Kit (Detection for 3 Genes) |
Shanghai ZJ Bio-Tech Co., Ltd., China |
RR-0479-02 |
P20200401 |
ORF1ab, N and E gene |
RT-PCR |
Nasopharyngeal or oropharyngeal swab samples |
|
81 |
Roche Diagnostics (M) Sdn Bhd |
COBAS SARS-CoV-2 & Influenza A/B Nucleic Acid Test for use on the COBAS LIAT System |
Roche Molecular System, Inc. |
P/N: 09211101190 (20 tests / kit) |
10419Y |
- |
RT-PCR (POCT) |
Nasal, nasopharyngeal and oropharyngeal swab |
|
82 |
Wija Pharma Sdn Bhd |
iONEBIO iLAMP Novel-CoV19 Detetion Kit |
iONEBIO Co., Ltd Korea |
REF. : CoV19-iLAMP |
KLJun09A10000 |
- |
RT-LAMP |
Nasopharyngeal (NPS) and Oropharyngeal swab (OPS) |
|
83 |
Simson Trading Sdn Bhd |
Fosun 2019-nCoV qPCR |
Shanghai Fosun Long March Medical Science Co., Ltd. |
PCSYHF02-a (48 tests/kit); PCSYHF03-a (96 tests/kit). |
N/A |
ORF1ab, N and E gene |
RT-PCR |
Nasopharyngeal or oropharyngeal swab samples |
|
84 |
Translab (M) Sdn Bhd |
EasyNAT Novel Coronavirus (2019-nCoV) RNA (Isothermal Amplification- Real Time Fluorescence Assay) |
Ustar Biotechnologies (Hangzhou) Ltd, China. |
Ref. : U20223 |
20210615 |
ORF1ab and N gene |
RT-LAMP POCT |
Nasopharyngeal (NPS) and Oropharyngeal swab (OPS) |
|
85 |
Next Gene Scientific Sdn Bhd |
NEXdia™ 2019-nCoV Detection KIt |
Genes Laboratories, Republic of Korea |
Model name: NexD-C1DTH (100 tests/kit) |
V159L1 |
RdRP gene, N gene, E gene |
RT-PCR |
Nasopharyngeal (NPS) and Oropharyngeal swab (OPS) |
|
86 |
Asia Coding Centre Sdn Bhd |
VERI-Q PCR 316 Coronavirus Disease 2019 (COVID-19) Detection Kit nCoV-QS |
MiCo Biomed., Ltd., Korea. |
7K105 |
M224221DY1SA |
ORF3a gene, N gene |
Rapid Molecular |
Nasopharyngeal (NPS)/ Oropharyngeal swab (NPS/OPS) |
|
87 |
MyGenome Sdn Bhd. |
Detection Kit for 2019-nCoV RNA (Multiple RT-PCR Fluorescence Probing) (Lyophilised) |
Guangdong Huayin Medicine Science Co., Ltd |
HY06112 |
20200401 |
ORF1 a/b gene, N gene, and S gene |
RT-PCR |
Oropharyngeal swab |
|
88 |
INTERSCIENCE SDN BHD |
StrongStep® |
Nanjing Liming Bio-products Co. Ltd,China |
500190 |
62104001A |
N gene, E gene and ORF1ab gene |
RT-PCR |
Nasopharyngeal (NPS) and Oropharyngeal swab (OPS) |
|
89 |
TRI-G Technologies Sdn Bhd |
1copyTM COVID-19 qPCR Triplex Kit |
1 drop Inc. Korea |
M23MD100T |
M231B2400 |
N gene, E gene |
RT-PCR |
Nasopharyngeal swab (NPS) and Oropharyngeal swab (OPS) |
|
90 |
Dedikasi Semangat (M) Sdn Bhd |
BioGerm Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (PCR-Fluorescence Probing) |
Shanghai BioGerm Medical Technology Co., Ltd China. |
n/a |
20210521B |
ORF1ab and N gene |
RT-PCR |
Nasopharyngeal & Oropharyngeal swab |
|
91 |
Neopharma Biotech Asia Sdn Bhd |
SSf-COVID-19 |
Seasun Biomaterials Inc., Korea |
SS-9970 |
AH-021005 |
RdRp gene, E gene |
RT-PCR |
Nasopharyngeal swab and Oropharyngeal swab |
|
92 |
Almedico Sdn Bhd |
StrongStep® Novel Coronavirus (SARS-CoV-2) Multiplex Reat-Time PCR Kit |
Nanjing Liming Bio-products Co., Ltd. |
500190 |
62104001A |
N gene, E gene and ORF1ab gene |
RT-PCR |
Nasopharyngeal swab (NPS) combined with oropharyngeal swab (OPS) |
|
93 |
Omega Tech Facilities Sdn Bhd |
SARS-CoV-2 RT PCR Multiplex Diagnostic Kit |
HA TECH PTY Ltd. Sydney Australia |
NAT-01 |
NAT-01-210901 |
N gene, E gene and ORF1ab gene |
RT-PCR |
Nasopharyngeal swab (NPS) & Oropharyngeal swab (OPS) |
|
94 |
Interscience Sdn Bhd |
ALINITY m RESP-4-PLEX AMPLIFICATION REAGENT KIT AND CONTROL KIT |
Abbott Molecular Inc. USA |
09N79-090 and 09N79-080 |
Alinity m RESP-4-Plex AMP Kit: 518877 |
RdRp gene and N gene |
RT-PCR |
Nasopharyngeal swab (NPS) in VTM |
|
95 |
MonitorBio Group Sdn Bhd |
MBG COVID-19 PCR Test |
MonitorBio Group Sdn Bhd |
MBG |
MBG02092106 |
N gene and ORF1a gene |
RT-qPCR |
Nasopharyngeal swab (NPS) and Oropharyngeal swab (OPS) in VTM |
|
96 |
Trumer Diagnostics Sdn Bhd |
PCL COVID-19 Speedy RT-PCR |
PCL Inc. Republic of Korea |
MD02 |
MD02_210927 |
N gene, E gene, RNAse P gene |
RT-PCR |
Nasopharyngeal swab (NPS) and Oropharyngeal swab (OPS) |
|
NO |
COMPANY NAME |
PRODUCT NAME |
MANUFACTURER |
IDENTIFIER |
LOT NUMBER |
DETECTION |
SAMPLE TYPE |
|
1 |
MY E.G. Services Berhad |
Diagnostic Kit for Antibody IgM/IgG of Novel Coronavirus COVID-19 |
Shanghai Liangrun Biomedicine Technology Co., Ltd. P.R. China |
N/A |
N/A |
RTK Antibody |
Serum |
|
2 |
Science Valley Sdn Bhd |
STANDARD Q COVID-19 IgM/IgG Combo |
SD Biosensor, Inc. Republic of Korea |
Ref. No: Q-NCOV-01C |
BQC05020001 COD220001 |
RTK Antibody |
Serum |
|
3 |
Roche Diagnostics (M) Sdn Bhd |
Standard Q SARS-CoV-2 Rapid Antibody Test |
SD Biosensor, Inc. Republic of Korea |
9901-NCOV-02C |
QCO5020029A |
RTK Antibody |
Serum |
|
4 |
Premier Diagnostics Sdn Bhd |
Asan Easy Test COVID-19 IgG/IgM |
Asan Pharmaceutical Co., Ltd. Republic of Korea |
AM3471-K |
EIX002 |
RTK Antibody |
Serum |
|
5 |
ER Medicare |
Maccura SARS-CoV-2 Antibody Assay Kit |
Maccura Biotechnology Co., Ltd. P.R. China. |
1M4102079 |
320081 |
RTK Antibody |
Serum |
|
6 |
Malaysian Diagnostics Corporation Sdn Bhd |
SARS-CoV-2 IgM/IgG Antibody Test Kit (Colloidal Gold Method) |
ZYbio Inc. P.R. China |
N/A |
H200500 |
RTK Antibody |
Serum |
|
7 |
Vitramed (Asia) Sdn Bhd |
careUS™ COVID-19 IgM IgG |
Wells Bio Inc. Republic of Korea |
BR034A |
RCO20E251 |
RTK Antibody |
Serum |
|
8 |
Green Health Global Sdn Bhd |
Covid-19 IgG/IgM Rapid Test Cassette (Whole blood/Serum/Plasma) |
Zhejiang Orient Gene Biotech Co Ltd. P.R. China |
N/A |
2003242 |
RTK Antibody |
Serum |
|
9 |
VQM Marketing Sdn Bhd |
2019-nCoV IgG/IgM Rapid Test Cassette |
Hangzhou AllTest Biotech Co. Ltd. P.R. China |
INCP-402 |
NCP20050072 |
RTK Antibody |
Serum |
|
10 |
Acutest System (M) Sdn Bhd |
Cellex qSARS-CoV-2 IgG/IgM Cassette Rapid Test |
Cellex Inc. USA |
N/A |
ZCFX20200609WI5513C-3 |
RTK Antibody |
Serum |
|
11 |
Pall Thai Medical Sdn Bhd |
Covid-19 Rapid IgG/IgM Combined Antibody Pre-Screening Kit |
Spring Healthcare Services AG Switzerland |
ERCSS05310 |
ERCSSO5310 |
RTK Antibody |
Serum |
|
12 |
Tri-G Technologies Sdn Bhd |
Rightsign Covid-19 IgG/IgM Rapid Test Cassette |
Hangzhoou Biotest Biotech Co., Ltd. P.R.China |
N/A |
COV2008002-S |
RTK Antibody |
Serum |
|
13 |
DKSH Technology Sdn Bhd |
Biolidics 2019-nCoV IgG/IgM Antibody Detection Kit |
Biolidics Ltd, Singapore |
CBB-F015016-B1 |
V5020042652B |
RTK Antibody |
Serum |
|
14 |
Merlin Medic Sdn Bhd |
Covid-19 lgG/lgM Rapid Test Cassette (Whole Blood/Serum/Plasma) |
HEALGEN Scientific Limited Liability Company, USA. |
GCCOV-402a |
2006084 |
RTK Antibody |
Serum |
|
15 |
Medical Innovation Ventures Sdn. |
ProDetect® COVID-19 IgG/IgM Rapid Test (Dipstick) |
Medical Innovation Ventures Sdn. Bhd. Penang, Malaysia |
PR-CVD |
PRCVD20OCT16G |
RTK Antibody |
Serum |
|
16 |
Medical Innovation Ventures Sdn. Bhd. Penang, Malaysia |
ProDetect® COVID-19 IgG/IgM Rapid Test (cassette) |
Medical Innovation Ventures Sdn. Bhd. Penang, Malaysia |
PR-CVDC |
RRCVDC20NOVOV03 |
RTK Antibody |
Serum |
|
17 |
Translab (M) Sdn Bhd |
NADAL® COVID-19 IgG/IgM Test (test cassette) |
nal von minden GmbH |
243001N |
174159 |
RTK Antibody |
Serum |
|
18 |
Exza Medical Sdn Bhd |
Hightop SARS-CoV-2 IgM/IgG Antibody Rapid Test |
Qingdao Hightop Biotech Co., Ltd, China |
SARS-CoV-2 IgM/IgG Antibody Rapid Test (40 tests/kit) |
COV1252009C |
RTK Antibody |
Serum |
|
19 |
Reszon Diagnostics International Sdn. Bhd. |
Reszon COVID 19 Rapid IgG/IgM Test |
Reszon Diagnostics International Sdn. Bhd. |
RCV-RD0101, |
20201101 |
RTK Antibody |
Serum |
|
20 |
Siemens Healthcare Sdn Bhd |
ADVIA Centaur® SARS-CoV-2 Total (COV2T) ADVIA Centaur® SARS-CoV-2 Total Quality Control (COV2T QC) |
Siemens Healthcare Diagnostics Inc. USA |
Ref: 11206710 (100 test//kit) |
709004 |
Antibody Assay |
Serum |
|
21 |
Siemens Healthcare Sdn Bhd |
Atellica® IM SARS-CoV-2 Total (COV2T) Atellica® IM SARS-CoV-2 Total Quality Control (COV2T QC) |
Siemens Healthcare Diagnostics Inc. USA |
Ref: 11206711 (100 test) |
709004 |
Antibody Assay |
Serum |
|
22 |
Roche Diagnostics (M) Sdn Bhd |
Elecsys® Anti-SARS-CoV-2 CalSet Anti-SARS-CoV-2 S PreciControl Anti-SARS-CoV-2 S |
Roche Diagnostics GmbH, Mannheim, Germany |
09203095190 |
92030955500 |
Antibody Assay |
Serum |
|
23 |
Abbott Laboratories (M) Sdn Bhd |
SARS-CoV-2 IgG Reagent Kit SARS-CoV-2 IgG Calibrator Kit SARS-CoV-2 IgG Control Kit |
Abbott Ireland, Diagnostics Division, Sligo, Ireland. |
SARS-CoV-2 IgG Reagent Kit (List No. 6R90-22) |
18099FN00 |
Antibody Assay |
Serum |
|
24 |
Beckman Coulter Malaysia |
Access SARS-CoV-2 IgG Access SARS-CoV-2 IgG Calibrator Access SARS-CoV-2 IgG QC:QC (Quality Control) materials |
Beckman Coulter, Inc. CA U.S.A. |
C58961 C58963 C58964 |
971197 |
Antibody Assay |
Serum |
|
25 |
Bio Universal Med Sdn Bhd |
ImmuSAFE™ COVID+ Biochip Test |
Applied Microarrays, Inc. USA |
39508H |
N/A |
Antibody MicroArray |
Serum |
|
26 |
DiagnostiCARE Sdn Bhd |
VITROS Immunodiagnostic Products Anti-SARS-2 Total Reagent Pack |
Ortho-Clinical Diagnostics, Inc. New York |
6199922 6199923 6199924 |
240 |
Antibody Assay |
Serum |
|
27 |
DiagnostiCARE Sdn Bhd |
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG |
Ortho-Clinical Diagnostics |
6199919, |
160 |
Antibody Assay |
Serum |
|
28 |
Roche Diagnostics (M) Sdn Bhd |
Elecsys Anti-SARS-CoV-2 |
Roche Diagnostics GmbH, Mannheim, Germany |
9203095190 |
9203095500 |
Antibody Assay |
Serum |
|
29 |
Siemens Healthcare Sdn Bhd |
ADVIA Centaur® SARS-CoV-2 IgG (sCOVG) |
Siemens Healthcare Diagnostics Inc. Tarrytown, NY USA |
11207376-100test |
4058001 |
Antibody Assay |
Serum |
|
30 |
Siemens Healthcare Sdn Bhd |
Atellica® IM SARS-CoV-2 IgG (sCOVG) |
Siemens Healthcare Diagnostics Inc. Tarrytown, NY USA |
Ref: 11207386 (100 test/kit) |
4051001 |
Antibody Assay |
Serum |
|
31 |
Premier Diagnostics Sdn Bhd |
WANTAI SARS-COV-2 Ab ELISA (Total) |
Beijing Wantai Biological Pharmacy Enterprise Co., Ltd, Beijing, China |
ws-1096 |
NCOA20201001 |
Antibody Assay |
Serum |
|
32 |
Premier Diagnostics Sdn Bhd |
COVID-19 IgG/IgM Rapid Test Device (Whole Blood/ Serum/ Plasma) |
Assure Tech. (Hangzhou) Co., Ltd, China |
COV-W23M |
SR2021010037 |
RTK Antibody |
Serum |
|
33 |
Chemopharma Sdn Bhd |
Anti-SARS-CoV-2 ELISA (IgG) |
Euroimmun Medizinische Labordiagnostika AG, Deutchland |
EI 2606-9601G |
E201029AW |
Antibody Assay |
Serum |
|
34 |
Chimera-Tech Sdn Bhd |
Neutralizing Antibody of SARS-CoV-2 Test |
Anbio (Xiamen) Biotechnology Co., Ltd |
A6021501 |
20201221601 |
Neutralizing Antibody Assay |
Serum |
|
35 |
Abbott Laboratories (M) Sdn Bhd |
SARS-CoV-2 IgM (Architect i system) |
Abott Ireland, Ireland |
SARS-CoV-2 IgM Reagent Kit (List No. 6R87-22) 100 tests, (List No. 6R87-32) 500 tests |
23537FN00 |
Antibody Assay |
Serum |
|
36 |
Premier Diagnostics Sdn Bhd |
E Diagnosis COVID-19(SARS-CoV-2) IgM/IgG Antibody Test Kit |
Wuhan EasyDiagnosis Biomedicine Co., Ltd. P.R. China |
2. 002932 |
20070101 |
RTK Antibody |
Serum |
|
37 |
Poliklinik Plaza Damansara |
E Diagnosis COVID-19(SARS-CoV-2) IgM/IgG Antibody Test Kit |
Wuhan EasyDiagnosis Biomedicine Co., Ltd. P.R. China |
2. 002932 |
20030401 |
RTK Antibody |
Serum |
|
38 |
Azion Healthcare Sdn Bhd |
Bel TEST-It! SARS-CoV-2 IgM/IgG rapid test |
PharmACT GmbH, |
CV.10.01 CV.10.10 CV.10.100 |
20200418001 |
RTK Antibody |
Serum |
|
39 |
Biomarketing Services (M) Sdn Bhd |
MAGLUMI™ 2019-nCoV IgG (CLIA) |
Shenzen New Industries Biomedical Engineering Co., Ltd, China. |
130219015M |
2722001301 |
RTK Antibody |
Serum |
|
40 |
Biomarketing Services (M) Sdn Bhd |
MAGLUMI™ 2019-nCoV IgM (CLIA) |
Shenzen New Industries Biomedical Engineering Co., Ltd, China. |
130219016M |
2712001501 |
RTK Antibody |
Serum |
|
41 |
Pharmaniaga Marketing Sdn Bhd |
BIOTRON COVID-19 IgG/IgM Rapid Test Kit (Immuno-Chromatography) |
Guangzhou Biotron Technology Co., Ltd, China |
N/A |
A3011062820 |
RTK Antibody |
Serum |
|
42 |
Chimera-Tech Sdn Bhd |
MP Diagnostic ASSURE SARS-CoV-2 IgG/IgM Rapid Test |
MP Biomedicals Asia Pacific Pte. Ltd, Singapore |
43140-020 |
DC1001 |
RTK Antibody |
Serum |
|
43 |
Translab (M) Sdn Bhd |
Maccura SARS-CoV-2 IgG (CLIA) |
Maccura Biotechnology Co., Ltd, China |
EIM4407014 |
920061 |
Antibody Assay |
Serum |
|
44 |
Alere Health Sdn Bhd |
Panbio™COVID-19 IgG/IgM Rapid Test Device (Figerstick Whole Blood/ Venous Whole Blood/ Serum/Plasma) |
Abbott Rapid Diagnostics Jena GmbH, Germany |
ICO-T402 |
COV0082022 |
RTK Antibody |
Serum |
|
45 |
Chemopharm Sdn Bhd |
Mindray SARS-CoV-2 IgM (CLIA) |
Shenzhen Mindray Bio-Medical Electronics Co., Ltd, China |
105-019873-00 |
2020050303 |
Antibody |
Serum |
|
46 |
Chemopharm Sdn Bhd |
Mindray SARS-CoV-2 IgG (CLIA) |
Shenzhen Mindray Bio-Medical Electronics Co., Ltd, China |
105-019883-00 |
2020050303 |
Antibody |
Serum |
|
47 |
Beckman Coulter |
Access SARS-CoV-2 IgM |
Beckman Coulter, Inc, Brea, CA, USA |
C58957 C58958 C58959 |
971288 |
Antibody Assay |
Serum |
|
48 |
Holista Biotech Sdn Bhd |
HECIN 2019 n-CoV IgM/IgG Antibody Test Kit (Colloidal gold method) |
Guangdong Hecin Scientific, Inc., China |
NL-CA002-2020-54429 |
20201101 |
RTK Antibody |
Serum |
|
49 |
Siemens Healthcare Sdn Bhd |
Dimension EXL SARS‑CoV‑2 Total Antibody Assay |
Siemens Healthcare Diagnostics Inc., USA |
REF: RF812, SMN:11417412 REF: KC813, SMN:11417413 REF: KC815, SMN:11417415 |
EA1253 |
Antibody Assay |
Serum |
|
50 |
Chemopharm Sdn Bhd |
BIOEASY 2019-Novel Coronavirus (2019-nCoV) IgG/IgM GICA Rapid Test (Colloidal Gold) |
Shenzhen Bioeasy Biotechnology Co., Ltd, People's Republic of China |
N/A |
2003N106 |
RTK Antibody |
Serum |
|
51 |
Abbott Laboratories (M) Sdn Bhd |
Alinity SARS-CoV-2 IgG (also referred to as SARSCoV-2 IgG) SARS-CoV-2 IgG Calibrator Kit (also referred to as CoV-2 IgG Cal) SARS-CoV-2 IgG Control Kit (also referred to as CoV-2 IgG Ctrls) |
Abbott Ireland Diagnostics Division Finisklin Business Park Sligo, Ireland |
06R9022 06R9032 06R9002 06R9012 |
25448FN00 |
Antibody Assay |
Serum |
|
52 |
Abbott Laboratories (M) Sdn Bhd |
Alinity SARS-CoV-2 IgM SARS-CoV-2 IgM Calibrator Kit SARS-CoV-2 IgM Control |
Abbott Ireland Diagnostics Division Finisklin Business Park Sligo, Ireland |
06R9122 06R9132 06R9112 |
25048FN00 |
Antibody Assay |
Serum |
|
53 |
Translab (M) Sdn. Bhd. |
Maccura SARS-CoV-2 IgM/IgG Antibody Assay Kit by Colloidal Gold Method – Strip |
Maccura Biotechnology Co. Ltd. Chengdu, People’s Republic of China |
EIM4103080 |
520192 |
RTK Antibody |
Serum |
|
54 |
Translab (M) Sdn. Bhd. |
Maccura SARS-CoV-2 IgM/IgG Antibody Assay Kit by Colloidal Gold Method – Cassette |
Maccura Biotechnology Co. Ltd. Chengdu, People’s Republic of China |
EIM4101080 EIM4102080 |
520192 |
RTK Antibody |
Serum |
|
55 |
HWGB Medical Devices & Supplies Sdn Bhd |
OJABIO SARS-CoV-2 Neutralizing Antibody Detection Kit (Colloidal Gold) |
Wenzhou OJA Biotechnology Co.,Ltd, China |
N/A |
ZKHZ21040901 |
RTK Neutralizing Antibody |
Serum |
|
56 |
Altica Sdn Bhd |
Core tests COVID-19 Neutralizing Ab Test |
Core Technology Co., Ltd, China |
B293-20 |
20210111 |
RTK Neutralizing Antibody |
Serum |
|
57 |
Nano Medic Care sdn Bhd |
ACON SARS CoV-2 IgG/IgM Rapid Test Cassette (Serum/ Plasma/Whole Blood) |
ACON Biotech (Hangzhou) Co., Ltd |
[L031-11711] |
COV0100002R |
RTK Antibody |
Serum |
|
58 |
Interscience Sdn Bhd |
StrongStep COVID-19 IgM/IgG Combo Rapid Test Device |
Nanjing Liming Bio-Products Co. Ltd., Nanjing, Jiangsu, China |
502090 |
502090 |
RTK Antibody |
Serum |
|
59 |
Biomarketing Services (M) Sdn Bhd |
MAGLUMI SARS-CoV-2 S-RBD IgG (CLIA) |
Shenzhen New Industries Biomedical Engineering Co., Ltd, China. |
130219017M: 100 tests |
27021030501 |
Antibody Assay |
Serum |
|
60 |
Translab (M) Sdn Bhd |
Zybio 2019-nCoV Neutralizing Antibody Assay (Colloidal Gold) |
Zybio Inc., China |
2100101 |
310201 |
RTK Neutralizing Antibody |
Serum |
|
61 |
Medic Sc Sdn Bhd |
AESKULISA® SARS-CoV-2 S1 IgG |
AESKU.DIAGNOSTICS GmbH & Co. KG, Germany |
6126 : IgG |
20480 |
Antibody Assay |
Serum |
|
62 |
Biomarketing Services (M) Sdn Bhd |
cPass™ SARS-CoV-2 Neutralizing Antibody Detection Kit |
Genscript Biotech (Singapore) Pte. Ltd. Singapore. |
REF: L00847-B (96 tests) |
A210202 |
Antibody Assay- Neutralizing Antibody |
Serum |
|
63 |
Chemopharm Sdn Bhd |
Mindray SARS-CoV-2 Neutralizing Antibodies (CLIA) |
Shenzhen Mindray io-Medical Electronics Co., Ltd, China |
105-020771-00, |
2021010100 |
Neutralizing Antibody Assay |
Serum |
|
64 |
Lab IVF (M) Sdn Bhd |
Leccurate SARS-CoV-2 Antibody Test (Colloidal Gold Immunochromatography) |
Beijing lepu Medical Technology Co., Ltd., China |
N/A |
21CG2501X |
RTK Antibody |
Serum |
|
65 |
Abbott Laboratories (M) Sdn Bhd |
ARCHITECT SARS-CoV-2 IgG II Quant |
Abbott Ireland, Ireland |
6S60-22 |
27093FN00 |
Antibody Assay |
Serum |
|
66 |
Chemopharm Sdn Bhd |
Mindray SARS-CoV-2 Total Antibodies (CLIA) |
Shenzhen Mindray Bio-Medical Electronics Co., Ltd, China |
105-020775-00 |
2021010400 |
Antibody Assay |
Serum |
|
67 |
Chemopharm Sdn Bhd |
Mindray SARS-CoV-2 S-RBD IgG (CLIA) |
Shenzhen Mindray Bio-Medical Electronics Co., Ltd, China |
105-020773-00 |
2021010100 |
Antibody Assay |
Serum |
|
68 |
DW Labs Sdn Bhd |
SARS-CoV-2 Neutralizing Antibody Test Kit (LFIA) |
Jiangsu Medomics Medical Technology Co., Ltd |
1030-01 |
20210204 |
Neutralizing Antibody Assay |
Serum |
|
69 |
EB Holding Sdn Bhd |
SGT SARS-CoV-2 In Vitro Neutralizing Antibody Test (IvnAT) |
Sugentech, Inc, Korea. |
CONE001E |
CONE21901 |
Neutralizing Antibody |
Serum |
|
70 |
Daiichi Biotech Services Sdn Bhd |
UNICELL-2019-nCoV Nab (Neutralizing Antibody) |
Shenzhen YHLO Biotech Co., Ltd., Shenzhen, China. |
F86243 |
20210303 |
Neutralizing Antibody |
Serum |
|
71 |
Abbott Laboratories (M) Sdn Bhd |
Alinity i SARS-CoV-2 IgG II Quant |
Abbott Ireland, Diagnostic Division, Finiskin Business Park, Sligo Ireland. |
06S6122 [100 tests/kit] & 06S6132 [500 tests/kit] |
27525FN00 |
Antibody Assay |
Serum |
|
72 |
Tri-G Technologies Sdn Bhd |
Bioscience Novel Coronavirus (2019-nCoV) Neutralizing Antibody Rapid Test |
Bioscience (Tianjin) Diagnostic technology Co., Ltd, China. |
210222CG |
20210206 |
Neutralizing Antibody |
Serum |
|
73 |
Tri-G Technologies Sdn Bhd |
RightSign SARS-CoV-2 Neutralizing Antibody Rapid Test Cassette |
Hangzhou Biotest Biotech Co., Ltd, China. |
ISNB-C41 |
SNB2106006-S |
Neutralizing Antibody |
Serum |
|
74 |
Translab (M) Sdn Bhd |
Maccura SARS-CoV-2 Neutralizing Antibody Kit (CLIA) |
Maccura Biotechnology Co., Ltd. |
EIM4409042: 25 Tests |
421011 |
Neutralizing Antibody |
Serum |
|
75 |
Medical Innovation Ventures Sdn Bhd |
Finecare™ 2019-nCoV RBD Antibody Test |
Guangzhou Wondfo Biotech Co. Ltd., China |
W290 |
W-290P0007/08 |
RTK Antibody |
Serum |
|
76 |
Neoscience Sdn Bhd |
STANDARD Q COVID-19 IgM/IgG Plus Test |
SD Biosensor, Inc |
Reference No.:Q-NCOV-02C |
QCO7021006A |
RTK Antibody |
Serum |
|
77 |
Simson Trading Sdn Bhd |
LYHER COVID-19 Neutralizing Antibody Test Kit |
Hangzhou Laihe Biotech Co., Ltd., China. |
303057 |
2107061 |
Neutralizing Antibody |
Serum |
|
78 |
Medinics (M) Sdn Bhd |
Beright™ SARS-CoV-2 S-RBD IgG Antibody Rapid Test |
Hangzhou AllTest Biotech Co., Ltd Zheijang P.R China. |
ICSG-402 |
20210507 |
RTK Antibody |
Serum |
|
79 |
Premier Diagnostics Sdn Bhd. |
Restalyst COVID19-REAAD™ Anti-SARS-CoV-2 IgG ELISA |
Restalyst Pte Ltd Singapore |
N/A |
SL25 |
Antibody Assay |
Serum |
|
80 |
Teda Wellness Solutions Sdn Bhd |
LYHER COVID-19 Neutralizing Antibody |
Hangzhou Laihe Biotech Co., Ltd, China |
303057 |
2107061 |
Neutralizing Antibody |
Serum |
|
81 |
Beckman Coulter Malaysia Sdn Bhd |
ACCESS SARS-CoV-2 IgG II |
Beckman Coulter, Inc., 250 S. Kraemer Blvd., Brea, CA 92821 U.S.A. |
C69057 |
124558 |
Antibody Assay |
Serum |
|
82 |
Premier Diagnostics Sdn Bhd |
Wantai SARS-CoV-2 NAb ELISA |
Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. |
WS-1596 |
NCOVNAI20210401 |
Neutralizing Antibody |
Serum |
|
83 |
AcuTest System (M) Sdn Bhd |
UNSCIENCE Anti-SARS-CoV-2 Neutralization Antibody Test Kit (Immunofluorescence Assay) |
Wuhan UNscience Biotechnology Co., Ltd., Wuhan, Hubei, China. |
CP04006-25 |
20210531 |
Neutralizing Antibody |
Serum |
|
84 |
Biomarketing Services (M) Sdn Bhd |
MAGLUMI SARS-CoV-2 Neutralizing Antibody (CLIA) |
Shenzen New Industries Biomedical Engineering Co., Ltd. |
130219027M:100 tests/kit |
300210221 |
Neutralizing Antibody |
Serum |
|
85 |
Dedikasi Semangat Sdn Bhd |
BioGerm Diagnostic Kit for 2019-nCoV IgM/IgG Antibody (Colloidal Gold) |
Shanghai BioGerm Medical Technology Co., Ltd China. |
Not available |
20210313A |
RTK Antibody |
Serum |
|
86 |
Chemopharm Sdn Bhd |
SARS-CoV-2 NeutraLISA |
EUROIMMUN Medizinische Labordiagnostika AG , Germany. |
EI 2606-9601-4G |
E210623AO |
Neutralizing Antibody |
Serum |
|
87 |
Pantasniaga Sdn Bhd |
Wondfo 2019-nCoV RBD Antibody Rapid Test |
Guangzhou Wondfo Biotech Co., Ltd., P.R. China |
W632 |
W63210422YZ |
RTK Antibody |
Serum |
|
88 |
JKS Biomedical Sdn. Bhd. |
DNK 2019-nCoV IgG/IgM Rapid Test |
Dynamiker Biotechnology (Tianjin) Co., Ltd. |
DNK-1419-1 |
210401-HW |
RTK Antibody |
Serum |
|
89 |
Conan Medical Technology Berhad |
SARS-CoV-2 Neutralizing Antibodies Test Rapid Test Kit System |
Xiamen Wiz Biotech Co., Ltd. China |
53232104; WIZ-A10 |
2021042506 |
Neutralizing Antibody |
Serum |
|
90 |
Daiichi Biotech Services Sdn Bhd |
GLINE-2019-nCoV NAb (Neutralization Antibody) |
Shenzhen YHLO Biotech Co., Ltd. |
G86250 |
20210000602 |
Neutralizing Antibody |
Serum |
|
91 |
Chemopharm Sdn Bhd |
Anti-SARS-CoV-2 QuantiVac ELISA (IgG) |
EUROIMMUN Medizinische Labordiagnostika AG |
EI 2606-9601-10 G |
E210706BU |
Antibody Assay |
Serum |
|
92 |
Top Biotech Sdn Bhd |
TOP RAPID COVID-19 Rapid Antibody IgG/IgM Test Kit |
Top Biotech Sdn Bhd, Malaysia |
Premium Model (with accessory) & Base Model (without accessory) |
TBCV03704103S |
RTK Antibody |
Serum |
|
93 |
VQM Marketing Sdn Bhd |
AllTest SARS-CoV-2 S-RBD IgG Antibody Rapid Test (Whole Blood/Serum/Plasma) |
Hangzhou AllTest Biotech Co., Ltd Zhejiang, P.R. China. |
ICSG-402 |
ATCS621070011 |
RTK Antibody |
Serum |
|
94 |
Translab (M) Sdn Bhd |
NADAL® COVID-19 S1-Nab Test (Test Casette) |
Nal Von Minden GmbH |
243301N-20 |
SNB2 101011-SG01 |
Neutralizing Antibody |
Serum |
|
95 |
Nano Medic Care Sdn. Bhd. |
Accufast COVID-19 Neutralizing Ab Test |
Bao Ruiyuan Biotech (Beijing) Co., Ltd. China |
BR30-21 |
20210719NEU |
Neutralizing Antibody |
Serum |
|
96 |
Tri-G Technologies Sdn Bhd |
COVID-19 Neutralizing Antibody Test Kit (Colloidal Gold) |
Anhui DeepBlue Medical Technology Co., Ltd. |
N/A |
20210701 |
Neutralizing Antibody |
Serum |
|
97 |
Translab (M) Sdn Bhd |
SARS-CoV-2 Neutralizing Antibodies Test Kit (Enzyme Linked Immunosorbent Assay) |
Wuxi Biohermes Bio & Medical Technology Co., Ltd. |
COV-S41 |
ECV211011011 |
Neutralizing Antibody |
Serum |
|
98 |
Medispec (M) Sdn Bhd |
Hightop SARS-CoV-2 IgM/IgG Antibody Rapid Test |
Qingdao Hightop Biotech Co., Ltd |
H100 |
COV-1210949 |
RTK Antibody |
Serum |