The list of RTK ANTIGEN (Self-Test) that is approved for Conditional Approval 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 evidence.
• the evaluation test results from testing facilities are according to the committee evaluation criteria set by Clinical expert panels.
• Supporting Documents for COVID-19 IVD Test Kits Conditional Approval.
The use of COVID-19 self- test kit shall be limited for screening purpose only and all test results need further confirmation using RT-PCR.
Below is the list of all tests that have been selected to date and the status is Conditional Approval (please note: list is updated on a routine basis).
Notes:
*Sample type is based on testing facility evaluation report.
|
NO |
COMPANY NAME |
PRODUCT NAME |
MANUFACTURER |
IDENTIFIER |
LOT NUMBER |
|
|
1 |
Reszon Diagnostic International Sdn Bhd |
Salixium-COVID-19 Rapid Antigen Rapid Test (Saliva/ Nasal Swab Samples) Sample type: Saliva and nasal swab samples (Mix Samples) |
Reszon Diagnostics International Sdn Bhd. selangor, Malaysia |
SLXHB1-0621001 |
SLXAGl-2105026 |
|
|
2 |
Citymedic Sdn Bhd |
Gmate® COVID-19 Ag Saliva for Home Use Sample type: Saliva |
Philosys Co., Ltd, Republic of Korea |
AG-020 |
CSIOUFAO |
|
|
3 |
Medinics (M) Sdn Bhd |
BERIGHT-COVID-19 Antigen Rapid Test Device (Oral Fluid) Sample type: Saliva
|
Hangzhou AllTest Biotech Co., Ltd. Zheijang, P.R. China |
ICOV-802H |
ATCOV21060076 |
|
| 4 | Neopharma Biotech Asia Sdn Bhd |
JusChek COVID-19 Antigen Rapid Test (Oral Fluid) Sample type: SalivaSample type: Saliva |
Hangzhou AllTest Biotech Co., Ltd Zheijang, P.R. China. | ICOV-802H | ATCOV21060078 | |
| 5 |
Global Science Sdn Bhd |
ALLTest COVID-19 Antigen Rapid Test (Oral Fluid) Sample type: Saliva |
Hangzhou AllTest Biotech Co., Ltd Zheijang, P.R. China. |
ICOV-802H | RATCOV21060077 | |
| 6 | Jingga Anggun Sdn Bhd |
Longsee 2019-nCoV Ag & Influenza A/B Rapid Co-Detection Kit (Immunochromatography) Home based Use Sample type: Saliva |
Guangdong Longsee Biomedical Co. Ltd.,Guangzhou,P.R. China | LS-C-T-005 | CT005210531 | |
| 7 | Hexamine Sdn Bhd |
Sichuan Xincheng (Diacegene) SARS-CoV-2 Antigen Assay
|
Sichuan Xincheng Biological Co. Ltd., P.R. China. | T4001W | 521042 | |
| 8 | Translab (M) Sdn Bhd |
Flowflex™ SARS-CoV-2 Antigen Rapid Test (Self-testing) Sample type: Nasal swab |
ACON Biotech (Hangzhou) Co., Ltd., P.R.China | L031-118M5 | COV1070026 | |
| 9 | Neoscience Sdn Bhd |
STANDARD™ Q COVID-19 Ag Saliva Home Test Sample type: Saliva |
SD Biosensor, Inc. Republic of Korea |
Ref No: Q-NCOV-02G Cat. No: 09COV131 |
52D2791AC | |
| 10 | Medical Innovation Ventures Sdn Bhd |
ProDetect™ COVID-19 Antigen Rapid Self-Test (Saliva) Sample type: Saliva |
Medical Innovation Ventures Sdn Bhd, Penang, Malaysia | PR-CVDCAgS | PR-CVDCAgS21JUL09 | |
| 11 | Dewina Consult Sdn Bhd |
NEWGENE Bioengineering COVID-19 Antigen Detection Kit Sample type: Saliva, Nasal Swab |
New Gene (Hangzhou) Bioengineering Co., Ltd. P.R. China | COVID-19-NG08 | 20210501-01 | |
| 12 | Tree Med Sdn Bhd |
Lituo COVID-19 Antigen Detection Kit (Colloidal Gold) Self Test Kit Sample type: Saliva |
Zhuhai Lituo Biotechnology Co., Ltd. P. R. China | LCV051 | 20210307 | |
| 13 | Pahang Pharmacy Sdn Bhd |
GRUENBANKA SARS-CoV-2 Antigen Detection Kit (Colloidal Gold Method) Sample type: Saliva |
Ningbo Lvtang Biotechnology Co. Ltd., Zhejiang P.R, China. | JQ-nCovAg-S | NI21G13BJQ | |
| 14 | Malaysian Diagnostics Corporation Sdn Bhd |
Humasis COVID-19 Ag Home Test (Self-Test) Sample type: Nasal swab |
Humasis Co. Ltd., Republic of Korea. |
ACOVAGS-7025 | COVGCF1015 | |
| 15 | Teda Wellness Solutions Sdn Bhd |
LYHER® Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold) Sample type: Nasal swab |
Hangzhou Laihe Biotech Co. Ltd. Zheijang, P.R. China |
30306 | 2105032 | |
| 16 | N.A.Z. Medical Supplies Sdn Bhd |
ALLTEST COVID-19 Antigen Rapid Test (Oral Fluid) Sample type: Saliva |
Hangzhou Alltest Biotech Co., Ltd.Hangzhou,P.R.China. |
ICOV-802H | ATCOV21070003 | |
| 17 |
Medinics (M) Sdn Bhd |
Beright™ SARS-CoV-2 Antigen Rapid Test (Nasal Swab) For Self-testing Sample type: Nasal swab |
Hangzhou AllTest Biotech Co.Ltd, P.R China. |
INCP-502H | ATNCP21070001 | |
| 18 | Roche Diagnostics (M) Sdn Bhd |
Roche SARS-CoV-2 Antigen Self-Test Nasal Sample type: Nasal swab |
SD Biosensor, Republic of Korea. |
9901-NCOV-06G / 09445323077 | 5822621T1 | |
| 19 | Onecare Biotech Sdn Bhd |
ARISTA™ COVID-19 Antigen Rapid Test Sample type: Nasal swab |
ARISTA Biotech Pte. Ltd., Singapore. | ARISTA-AG-L1EN-001 ARISTA-AG-L1MY-001 | 405-07006-2106018 | |
| 20 | SPD Scientific (M) Sdn Bhd |
Whistling™ Test 2019-nCoV Saliva Ag Easy Test Sample type: Saliva |
Guangzhou Decheng Biotechnology Co., Ltd, P.R. China. | 0709D6G001 0709D6G002 0709D6G005 0709D6G010 0709D6G020 0709D6G025 | 70210701 | |
| 21 |
Hygeia Instruments (Malaysia) Sdn Bhd |
Newgene Bioengineering COVID-19 Antigen Detection Kit (For Home Self-Use) Sample type: Saliva |
New Gene (Hangzhou) Bioengineering Co. Ltd., P.R. China. |
COVID-19-NG08 |
20210721-01 | |
| 22 |
Universal Therapeutics Sdn Bhd |
TIB SARS CoV-2 Antigen Rapid Test Kit Saliva Sample type: Saliva |
Triplex International Biosciences (China) Co., Ltd |
COV-3S |
72101 |
|
| 23 | Malaysian Diagnostics Corporation Sdn. Bhd. |
V-check 2019-nCoV Ag Saliva Rapid Test Card (Immunochromatography) Sample type: Saliva |
Guangdzhou Decheng Biotechnology Co., Ltd., P.R. China. | 0699C8X001 0699C8X005 0699C8X020 |
52821022C | |
| 24 | Interscience Sdn Bhd |
StrongStep® SARS-CoV-2 Antigen Rapid Test (Self-Test) Sample type: Nasal swab |
Nanjing Liming Bio-Products Co. Ltd., P.R. China. | 500200 | 2108001 | |
| 25 | IMP Enterprise Sdn Bhd |
Merlin SARS-CoV-2 Antigen Rapid Test Cassette Sample type: Nasal swab |
Merlin Biomedical (Xiamen) Co., Ltd., P.R.China. |
CP01750011 |
CG00121709 | |
| 26 |
IMP Enterprise Sdn Bhd |
Merlin SARS-CoV-2 Antigen Rapid Test Cassette Sample type: Saliva |
Merlin Biomedical (Xiamen) Co., Ltd., P.R.China. |
CP02140011 CP02150011 | CG00221703 | |
| 27 |
Onecare Biotech Sdn Bhd |
LEPU SARS-CoV-2 Antigen Rapid Test Sample type: Nasal swab |
Beijing Lepu Medical Technology Co., Ltd., P.R. China | CG3601 (1-piece pack) CG3605 (5-piece pack) CG3610 (10-piece pack) CG3625 (25-piece pack) CG3650 (50-piece pack) |
21CG3604F |
|
| 28 |
NeoScience Sdn Bhd |
STANDARD™ Q COVID-19 Ag Home Test Sample type: Nasal swab |
SD Biosensor Inc., Republic of Korea | Ref No: Q-NCOV-03G Cat No: 09COV130 (1T) 09COV130H (2T) 09COV130J (5T) 09COV130D(25T) |
58028L1T1 | |
| 29 | ExcelMed Sdn Bhd |
SARS-CoV-2 Antigen Detection Kit (Colloidal Gold Method) Home Use Self Test Kit Sample type: Saliva |
Xiamen Jiqing Biomedical Technology Co., Ltd., P.R.China |
WKI0032 |
RI21H17BMY |
|
| 30 | City Medic Sdn Bhd |
WONDFO 2019-nCoV Antigen Test (Lateral Flow Method) Self Test Saliva Sample type: Saliva |
Guangzhou Wondfo Biotech Co., Ltd. P.R. China. |
W633P0023, W633P0024 |
W63310818YZ |
|
| 31 |
Malaysian Diagnostics Corporation Sdn. Bhd. |
Lituo COVID-19 Antigen Detection Kit(Colloidal Gold) Sample type: Saliva |
Zhuhai Lituo Biotechnology, P.R.China |
LCV05 |
20210402 |
|
| 32 | Bles Medic Sdn Bhd |
Tigsun COVID-19 Saliva Antigen Rapid Test Sample type: Saliva |
Beijing Tigsun Diagnostics Co. Ltd., P.R. China | TG-1417 |
14172106
|
|
| 33 | Universal Therapeutics Sdn Bhd |
NEWGENE COVID-19 Antigen Detection Kit Sample type: Nasal swab, Saliva |
New Gene (Hangzhou) Bioengineering Co. Ltd., P.R. China. | NG-08 | 2021082001 | |
| 34 | PMAN Healthcare Specialist Sdn Bhd |
Ninonasal® Self-Test Sample type: Nasal swab |
NG Biotech Laboratories, France | NGB-COV-S23-302 | 210305-01-E | |
| 35 | Arterial Global Sdn. Bhd |
SARS-CoV-2 Antigen Rapid Test Cassette (Merlin) Sample type: Nasal swab |
Merlin Biomedical (Xiamen) Co., Ltd., P.R.China. | REF CP01750011 (1 test/kit) REF CP01760011 (20 tests/kit); REF CP01770011 (50 tests/kit) REF CP01800011 (1 test/kit); REF CP01810011 (20 tests/kit REF CP01820011 (50 tests/kit) |
CG00121508 | |
| 36 |
Gideons (Malaysia) Sdn Bhd |
Novel Coronavirus (2019-nCoV) Antigen Testing Kit (Colloidal Gold) Sample type: Saliva |
Nanjing Norman Biological Technology Co. Ltd., P.R , China | 1/25 |
S2052621 |
|
| 37 |
XinnerG Sdn Bhd |
Alltest SARS-CoV-2 Antigen Rapid Test (Nasal swab) for Self-Testing Sample type: Nasal swab |
Hangzhou AllTest Biotech Co., Ltd., P.R.China |
INCP-502H | ATNCP21070012 | |
| 38 | Damanyu Healthcare Sdn Bhd |
Zosbio 2019-nCoV Ag Rapid Test (Immunochromatography) Sample type: Nasal swab, Saliva |
Zhongxiu Science and Technology Co. Ltd., P.R. China |
056-B-PD-2 |
20210701 | |
| 39 | Medical Innovation Ventures Sdn.Bhd |
Sejoy SARS-CoV-2 Antigen Rapid Test Cassette Sample type: Saliva |
Hangzhou Sejoy Electronics & Instruments Co. Ltd., P.R. China |
COVG-602ST |
COVG210806 | |
| 40 | Medical Innovation Ventures Sdn.Bhd |
Wondfo 2019 nCoV Antigen Test (Lateral Flow Method) Sample type: Nasal swab |
Guangzhou Wondfo Biotech Co. Ltd., P.R China |
REF W634P0024, 1 test/kit REF W634P0028, 2 test/kit REF W634P0025, 5 test/ kit |
W63410813YZ |
|
| 41 | Vquest Sdn Bhd |
TestNGo COVID-19 Rapid Antigen Saliva Test SARS-CoV-2 Antigen Test Kit (Self-Test) Sample type: Saliva |
Shenzhen Ultra-Diagnostics Biotec Co. Ltd., P.R. China |
SC0238 (1 test per pack) SC0239 (10 test per pack) SC0225 (20 test per pack) |
21082106 | |
| 42 | Malaysian Diagnostics Corporation Sdn. Bhd. |
CAMTECH COVID-9 Antigen Rapid Self-Test Kit Sample type: Nasal swab |
Camtech Biomedical Pte Ltd Singapore | RTCSV | 21070110KS | |
| 43 | Premier Diagnostics Sdn Bhd |
Ecotest COVID-19 Antigen Nasal Test Kit Sample type: Nasal swab |
Assure Tech. (Hangzhou) Co., Ltd. P.R.China. | COV-S35002 | SR2021080003 | |
| 44 | Naturmax Sdn Bhd |
Hopegene COVID-19 Antigen Rapid Test Kit (Colloidal Gold) Sample type: Saliva |
Xiamen Hopegen Medical Technology Co. td., P.R China |
COVID-19 Antigen Rapid Test Kit (Colloidal Gold) CVD-RTK-SV |
220210702 |
|
| 45 | Jingga Anggun Sdn Bhd |
Empro Biomed COVID-19 Ag Nasal Self-Test Sample type: Nasal swab |
Jingga Anggun Sdn. Bhd, Malaysia | STK-419 | EBN 20210926 | |
| 46 | Conan Medical Technology Berhad |
Wiz Biotech SARS-CoV-2 Antigen Rapid Test Sample type: Nasal swab |
Xiamen Wiz Biotec Co. Ltd., P.R.China |
51432801 | 2021091704 | |
| 47 | Premier Diagnostics Sdn Bhd |
Ecotest Covid-19 Antigen Rapid Test Device (Saliva) Sample type: Saliva |
Assure Tech (Hangzhou) Co. Ltd. P.R. China |
COV-S23003 | I2109080 | |
| 48 | K-One MediTech Sdn Bhd |
Labnovation SARS-CoV-2 Antigen Saliva Rapid Test Kit Sample type: Saliva |
Labnovation Technologies Inc. P.R China | LX-401601 | 20210929 | |
| 49 | CTK BIOTECH SDN. BHD. |
OnSite® COVID-19 Ag Self-Test Sample type: Nasal swab |
CTK Biotech Inc. USA |
R0182CST | RD1930Da | |
| 50 | Malaysian Diagnostics Corporation Sdn Bhd |
NEWGENE COVID-19 Antigen Detection Kit Sample type: Nasal swab & Saliva |
New Gene (Hangzhou) Bioengineering Co., Ltd. P.R. China | COVID-19-NG08 | 20210801-01 | |
| 51 | Medinics (M) Sdn Bhd |
BERIGHT SARS-CoV-2 (COVID-19) Antigen Rapid Test Oral Fluid (Saliva) Sample type: Saliva |
Hangzhou AllTest Biotech Co.Ltd. P.R.China | ICOV-803H | ATCOV21080253 | |
| 52 | PETROJESS TRADING SDN BHD |
ARISTA™ COVID-19 Antigen Rapid Test Sample type: Nasal swab & Saliva |
ARISTA Biotech Pte. Ltd., Singapore |
ARISTA-AG-L1EN-001: ARISTA™ COVID-19 Antigen Rapid Test (Self Use) (1 test in single pack) ARISTA-AG-L1EN-005: ARISTA™ COVID-19 Antigen Rapid Test (Self Use) (5 tests in aggregate pack) ARISTA-AG-L1EN-010: ARISTA™ COVID-19 Antigen Rapid Test (Self Use) (10 tests in aggregate pack) ARISTA-AG-L1EN-020: ARISTA™ COVID-19 Antigen Rapid Test (Self Use) (20 tests in aggregate pack) ARISTA-AG-L1EN-200: ARISTA™ COVID-19 Antigen Rapid Test (Self Use) (200 tests bulk pack |
405-07006-2106018 | |
| 53 | ExcelMed Sdn Bhd |
Wikang SARS-CoV-2 Antigen Detection Kit (Colloidal Gold Method) Home use Sample type: Nasal swab |
Xiamen Jiqing Biomedical Technology Co., Ltd. P.R.China | WKI0028 | RI21120BMY | |
| 54 | Convemed Sdn Bhd |
VivaDiag SARS-CoV-2 Ag Rapid Test Sample type: Nasal swab |
VivaCheck Biotech (Hangzhou) Co., Ltd. P.R. China | VCD05-01-011 | SE2103063 | |
| 55 | EB Holdings Sdn Bhd. |
SGTi-flex COVID-19 Antigen Sample type: Nasal swab |
Sugentech INC Korea | CATGT001E0 CATGT002E0 CATGT005E0 |
CAGS21001 | |
| 56 | Solid Intellectual Sdn Bhd |
NEWGENE COVID-19 Antigen Detection Kit Sample type: Nasal swab & Saliva |
New Gene (Hangzhou) Bioengineering Co., Ltd. P.R. China | NG-08 | 2021082001 | |
| 57 | VQM Marketing Sdn Bhd |
ALLTEST COVID-19 Antigen Rapid Test (Oral Fluid) For Self Testing Sample type: Saliva |
Hangzhou AllTest Biotech Co., Ltd. P.R.China. | ICOV-802H | ATCOV2080091 | |
| 58 | ScienceVision Sdn Bhd |
RapidFor™ SARS-CoV-2 Saliva Antigen Test Kit (self-testing) Sample type: Saliva |
Vitrosens Biyoteknoloji Ltd. Sti ,Istanbul Turkey | VSCD05 | S0521100201 | |
| 59 | B.P. Lab Sdn. Bhd. |
Singclean COVID-19 Antigen Test Kit (Colloidal Gold) Sample type: Saliva |
Hangzhou Singclean Medical Products Co., Ltd.P.R.China | 6936020115018 | 59210917A1A | |
| 60 | Epic Science Sdn. Bhd. |
Dymind SARS-CoV-2 Antigen Test Kit (Colloidal Gold) Sample type: Saliva |
Shenzhen Dymind Biotechnology Co., Ltd.P.R.China | R0035 R0037 R0039 |
20220824 | |
| 61 | Axial Health Sdn. Bhd. |
Axial Health COVID-19 Saliva Antigen Rapid Test (Colloid Gold Immunochromatography) Sample type: Saliva |
WFR Medical Supplies SDN BHD,Penang, Malaysia | AX-V200 | 2021061504 | |
| 62 | Axial Health Sdn. Bhd. |
Axial Health COVID-19 Salivary Antigen Rapid Test (Colloid Gold Immunochromatography) Sample type: Saliva |
WFR Medical Supplies SDN BHD,Penang, Malaysia | AX-V100 | 2021061504 | |
| 63 | Medi Diastika Sdn Bhd |
CAS-ENVISION SARS-CoV-2 Antigen Rapid Detection (Self-Test) Sample type: Nasal swab & Saliva |
CAS-Envision Medical Technology Co., Ltd. P.R.China | CG201A | W202105001-STY-1 | |
| 64 | Aureumaex Medicare Marketing (M) Sdn Bhd |
One Step Test for SARS-CoV-2 Antigen (Colloidal Gold) Sample type: Nasal swab |
Getein Biotech Inc. P.R.China | CG20615 CG206152 CG206153 CG206155 CG206156 CG206157 CG206158 CG206159 CG2061510 CG2061512 CG2061515 CG2061520 CG2061525 |
PSC213020W | |
| 65 | Premier Diagnostics Sdn Bhd |
Ecotest COVID-19 Antigen Rapid Test Device (Nasal Swab) Sample type: Nasal swab |
Assure Tech. (Hangzhou) Co., Ltd.P.R.China | CoV-s23004H | SR2021080163 | |
| 66 | Premier Diagnostics Sdn Bhd |
Szybio COVID-19 Antigen Rapid Test Kit (Saliva) Sample type: Saliva |
Wuhan Life Origin Biotech Joint Stock Co., Ltd. P.R.China | SF36001 | C2107023301 | |
| 67 | MEDICAL INNOVATION VENTURES SDN.BHD |
ProDetect™ COVID-19 Antigen Rapid Self-Test Sample type: Nasal swab |
Medical Innovation Ventures Sdn. Bhd. Penang,Malaysia |
PR-CVDCAgNS PR-CVDCAgN1S PR-CVDCAgN5S PR-CVDCAgN20S |
PRCVDAgN121AUG04 | |
| 68 | Epic Science Sdn. Bhd. |
Dymind SARS-CoV-2 Antigen Test Kit (Colloidal Gold) Sample type: Nasal swab |
Shenzhen Dymind Biotechnology Co., Ltd.P.R.China |
R0029 R0030 R0034 |
2021082501 | |
| 69 | ALLIANCE INTEGRITY TRADING SDN. BHD |
Clungene® COVID-19 Antigen Rapid Test Sample type: Nasal swab |
Hangzhou Clongene Biotech Co., Ltd.P.R.China | ISCOVu002-700993 | S202109023 | |
| 70 | Convemed Sdn Bhd |
VivaDiagTM SARS-CoV-2 Ag Saliva Rapid Test Sample type: Saliva |
VivaCheck Biotech (Hangzhou) Co., Ltd.P.R.China | VCD17-01-012 | SE2103162 | |
| 71 | GEOMICO SDN BHD |
BHM® COVID-19 Antigen Rapid Test Sample type: Nasal swab |
Birmingham Biotech Ltd. England |
BBIO001 |
G2108003 | |
| 72 | Global Glades Medic Sdn. Bhd. |
One Step Test for SARS-CoV-2 Antigen (Colloidal Gold) (Saliva) Test Kit Sample type: Saliva |
Getein Biotech Inc. P.R China | CG20616 CG206162 CG206163 CG206165 CG206166 CG206167 CG206168 CG206169 CG2061610 CG2061612 CG2061615 CG2061620 CG2061625 |
PSC213031W | |
| 73 | Teda Wellness Solutions Sdn Bhd |
Raycus COVID-19 Ag Rapid Test Kit - Saliva self-testing Sample type: Saliva |
Anhui Raycus Biological Technology Co., Ltd.P.R.China | RC2021ST | C20211001 | |
| 74 | Jingga Anggun Sdn Bhd |
LONGSEE 2019-nCoV Ag Rapid Detection Kit (Immuno-Chromatography) Sample type: Saliva |
Guangdong Longsee Biomedical Co., Ltd. P.R.China | LS-C-T-008 | CT008210705 | |
| 75 | Rocky Scientific Instrumentation |
KISSH SARS-CoV-2 Antigen Test Kit (GICA)-Saliva Sample type: Saliva |
Shenzen Kisshealth Biotechnology Co., Ltd.P.R.China |
K602-1S K602-3S K602-5S |
20210825 | |
| 76 | SPD Scientific (M) Sdn Bhd |
V-Chek 2019-nCoV Antigen Rapid Test Kit (Immunochromatography) Sample type: Nasal swab |
Guangzhou Decheng Biotechnology Co., LTD. P.R. China | 0555C2X001 | 68210701 | |
| 77 | XinnerG Sdn Bhd |
Genrui SARS-CoV-2 Antigen Test Kit (Colloidal Gold) Sample type: Saliva |
Genrui Biotech Inc. P.R. China |
52104098 (1 test kit) 52112087 (5 test kit) 52026095 (25 test kit) |
20210618 | |
| 78 | Rapport Medilines Sdn. Bhd |
One-step Test for SARS-CoV-2 Antigen (Colloidal Gold) (Saliva) Sample type: Saliva |
Getein Biotech Inc. P.R.China | CG20616 CG206162 CG206163 CG206165 CG206166 CG206167 CG206168 CG206169 CG2061610 CG2061612 CG2061615 CG2061620 CG2061625 |
PSC213029W | |
| 79 | Dyna Source Sdn Bhd |
BioDetect Rapid SARS-CoV-2 Antigen Test Card (Self-test) Sample type: Nasal swab |
BioDetect (Xiamen) Biotechnology Co., Ltd. P.R.China | GMT102 | T220050901 | |
| 80 | SPD Scientific (M) Sdn. Bhd. |
Green Spring SARS-CoV-2 Antigen Rapid Test Kit(Colloidal Gold) Sample type: Nasal swab |
Shenzhen Lvshiyuan Biotechnology Co., Ltd.P.R.China | GF102B1S | 20210401 | |
| 81 | Watercress Communications Sdn Bhd |
eDiagnosis COVID-19 (SARS-CoV-2) Antigen Test Kit Sample type: Nasal swab |
Wuhan EasyDiagnosis Biomedicine Co., Ltd. P.R.China | W-AgH-20 (20 test kits) W-AgH-05S (5 test kits) W-AgH-01S (1 test kits) |
21070102 | |
| 82 | K-One MediTech Sdn Bhd |
Medkaire SARS-CoV-2 Antigen Kit (Saliva) Self-Testing Sample type: Saliva |
Goldsite Diagnostics Inc.P.R.China | CG123101 | 20210906 | |
| 83 | Starvillion Sdn Bhd |
GICA - TESTSEALABS® COVID-19 Antigen Test Cassette Sample type: Saliva |
Hangzhou Testea Biotechnology Co., Ltd.P.R.China | TCS 1903 | HJJ040102 | |
| 84 | N.A.Z Medical Supplies Sdn Bhd |
COVID-19 Salivary Antigen Rapid Test Kit (Colloidal Gold) Sample type: Saliva |
Jiangsu Konsung Bio-Medical Science and Technology Co., Ltd.P.R.China |
ICOVS-702G-4 ICOVS-702G-5 |
S3221072601 | |
| 85 | TS DIAGNOSTICS SDN BHD |
Forsure COVID-19 Antigen Rapid Test Kit (Oral Fluid) Sample type: Saliva |
TS Diagnostics Sdn Bhd, Taman Perindustrian Puchong, Selangor, Malaysia. | FS-CV190F-C30 | 21060053 | |
| 86 | Onecare Biotech Sdn Bhd |
Hongyu SARS-CoV-2 Rapid Test Kit Sample type: Saliva |
Zhejiang Hongyu Medical Commodity Co., Ltd.P.R.China | HY-05 | 210820 | |
| 87 | Teda Wellness Solutions Sdn Bhd |
Lyher Novel Coronavirus (COVID-19) Antigen Test Kit(Colloidal Gold) Sample type: Saliva |
Hangzhou Laihe Biotech Co., Ltd. P.R.China | 303107 | 2108070 | |
| 88 | Multiplex Enterprise |
Eagle Bio SARS-CoV-2 Antigen IVD Kit Lollipop (Self Testing) Sample type: Saliva |
Shenzhen Reagent Technology Co., Ltd. P.R.China | HN06 | 20210902-01 | |
| 89 | Smarttech Engineering and Resource Management Sdn Bhd |
GenFarm SARS-CoV-2 Antigen Detection Kit Sample type: Nasal swab & Saliva |
Ningbo Lvtang Biotechnology Co., Ltd. P.R.China | CovAg-NS | 20231017 | |
| 90 | Symbion Asia Sdn Bhd |
IHealth Novel Coronavirus (SARS-COV-2) Salivary Antigen Rapid Test Kits (Dipstick) Sample type: Saliva |
Symbion Asia Sdn Bhd, Kuala Lumpur, Malaysia | 6000011 | SE2110030 | |
| 91 | Prova Lab & Research Sdn Bhd |
COVID-19 Ag Rapid Saliva Test Device Sample type: Saliva |
Jiangsu Well Biotech Co., Ltd. P.R.China |
Cat# CO-03S1 | 2108131 | |
| 92 | Premier Diagnostics Sdn Bhd |
COVID-19 Antigen Saliva Test Kit Sample type: Saliva |
Assure Tech. (Hangzhou) Co., Ltd. P.R.China. | COV-S35 | SR2021090090 | |
| 93 | Surgical Solutions (M) Sdn Bhd |
Hongyu SARS-CoV-2 Ag Rapid Test Kit Sample type: Saliva |
Zhejiang Hongyu Medical Commodity Co., Ltd. P.R.China |
HY-05 | 211007 | |
| 94 | Innotech Healthcare Sdn Bhd |
COVID-19 Rapid Antigen Saliva Self-Test Kit (Colloidal Gold) Sample type: Saliva |
Bioneovan Co., Ltd. P.R. China | BG1910C | 202109003 | |
| 95 | Brands Direct International Sdn Bhd |
Safecare COVID-19 Antigen Rapid Test Kit (Swab) for Self-Testing Sample type: Nasal swab |
Safecare Biotech (Hangzhou) Co., Ltd P.R.China |
COV AG-6012H | COV21100408 | |
Updated: 17 Disember 2021
Source: Medical Device Authority, Ministry of Health Malaysia https://portal.mda.gov.my/
Article reference from: https://portal.mda.gov.my/announcement/631-self-test-covid-19-test-kit-for-conditional-approval-approved.html