SELF-TEST COVID-19 TEST KIT FOR CONDITIONAL APPROVAL (APPROVED)
SELF-TEST COVID-19 TEST KIT FOR CONDITIONAL APPROVAL (APPROVED)
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 New Lot No: 070211101 070211102 070211103 070211104 070211105 070211106 070211107 |
|
| 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 New Lot No: 69211102 |
|
| 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 New Lot Number: 21CG3610F |
|
| 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 New lot number: NI21L01AMY NI21L02AMY NI21K15AMY |
|
| 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 | 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 | |
| 47 | 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 | |
| 48 | CTK BIOTECH SDN. BHD. |
OnSite® COVID-19 Ag Self-Test Sample type: Nasal swab |
CTK Biotech Inc. USA |
R0182CST |
RD1930Da F0126T2A00DB F0210T2A00DB |
|
| 49 | 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 | |
| 50 | 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 | |
| 51 | 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 | |
| 52 | 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 New lot number: NI21K18BMY NI21LO3AMY |
|
| 53 | 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 | |
| 54 | EB Holdings Sdn Bhd. |
SGTi-flex COVID-19 Antigen Sample type: Nasal swab |
Sugentech INC Korea |
CAGT001E0 CAGT002E0 CAGT005E0 |
CAGS21001 | |
| 55 | 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 | |
| 56 | 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 | |
| 57 | ScienceVision Sdn Bhd |
RapidFor™ SARS-CoV-2 Saliva Antigen Test Kit (self-testing) Sample type: Saliva |
Vitrosens Biyoteknoloji Ltd. Sti ,Istanbul Turkey | VSCD05 | S0521100201 | |
| 58 | 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 | |
| 59 | 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 | |
| 60 | 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 | |
| 61 | 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 | |
| 62 | 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 | |
| 63 | 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 | |
| 64 | 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 | |
| 65 | 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 | |
| 66 | 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 | |
| 67 | 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 | |
| 68 | 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 | |
| 69 | 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 | |
| 70 | GEOMICO SDN BHD |
BHM® COVID-19 Antigen Rapid Test Sample type: Nasal swab |
Birmingham Biotech Ltd. England |
BBIO001 |
G2108003 | |
| 71 | 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 | |
| 72 | 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 | |
| 73 | 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 | |
| 74 | 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 | |
| 75 | 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 | |
| 76 | 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 | |
| 77 | 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 | |
| 78 | 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 | |
| 79 | 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 | |
| 80 | 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 | |
| 81 | 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 | |
| 82 | 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 | |
| 83 | 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 | 2109263 | |
| 84 | 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 | |
| 85 | 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 | |
| 86 | 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 | |
| 87 | 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 | |
| 88 | 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 | |
| 89 | 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 | |
| 90 | Premier Diagnostics Sdn Bhd |
COVID-19 Antigen Saliva Test Kit Sample type: Saliva |
Assure Tech. (Hangzhou) Co., Ltd. P.R.China. | COV-S35 | SR2021090090 | |
| 91 | 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 | |
| 92 | 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 | |
| 93 | 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 | |
| 94 | Medical Innovation Ventures Sdn Bhd |
Sejoy® SARS-CoV-2 Antigen Saliva Lolly Test Sample type: Saliva |
Hangzhou Sejoy Electronics & Instruments Co., Ltd. P.R.China | COVG-603 | 21102444 | |
| 95 | TT Medical Management Sdn Bhd |
2019-nCoV Antigen Rapid Test (Saliva) (Colloidal Gold) Sample type: Saliva |
Xiamen SinaDx Biomedicals Co., Ltd.P.R.China | RD0516D1 | 2021100801 | |
| 96 | Medispec (M) Sdn Bhd |
SARS-CoV-2 Ag Self-Test Kit (Colloidal Gold) Sample type: Saliva |
Shenzhen Watmind Medical Co., Ltd. P.R. China | LFA0401-1N/5N/25N | 21100604 | |
| 97 | Medispec (M) Sdn Bhd |
HIGHTOP COVID-19 RTK Antigen Saliva Self-Test (for Home Use) Sample type: Saliva |
Qingdao HighTop Biotech Co., Ltd.P.R.China | H100S-01 | COV-1210950 | |
| 98 | Amcen Lab Sdn Bhd |
AmTest COVID-19 Antigen Detection Kit (Colloidal Gold) Sample type: Saliva |
ZHUHAI LITUO BIOTECHNOLOGY CO. LTD P.R. China | ACV051 | 20210802 | |
| 99 | Y.S.P. INDUSTRIES (M) SDN. BHD. |
CHEMTRUE® COVID-19 (SARS-CoV-2) Antigen Rapid Test Kit Sample type: Saliva |
Shanghai Chemtron Biotech Co., Ltd. P.R.China | 8046C | B202108033 | |
| 100 | Dyna Source Sdn Bhd |
Rapid SARS-CoV-2 Antigen Test Card (Saliva) Sample type: Saliva |
BioDetect (Xiamen) Biotechology Co., Ltd.. P.R.China | GMT104 | T221081101 | |
| 101 | TT Medical Management Sdn Bhd |
KISSH SARS-CoV-2 Antigen Test Kit (GICA) Nasal (Anterior) Sample type: Nasal swab |
Shenzhen Kisshealth Biotechnology Co., Ltd. P.R.China | K602-1H | 20210727 | |
| 102 | DW Labs Sdn Bhd |
MEDOMICS SARS-CoV-2 Antigen Test Kit (LFIA) Layman's Test Sample type: Nasal swab |
Jiangsu Medomics Medical Technology Co., Ltd. P.R.China | 1031-14-01 | 20210729 | |
| 103 | ScienceVision Sdn Bhd |
SARS-CoV-2 Antigen Test Kit (Colloidal Gold) Sample type: Saliva |
Shenzhen Huian Biosci Technology Co., Ltd. P.R.China | 203-001 / 203-020 | 211001 | |
| 104 | CLA Medical 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 CG2061510 CG2061512 CG2061515 CG2061520 CG2061525 |
6SC216040W | |
| 105 | WYS Trading & Management Consultancy |
GLINE-2019-nCoV Antigen Saliva Sample type: Saliva |
Shenzhen YHLO Biotech Co., Ltd.P.R.China | G86259 (1T) | 20211001 | |
| 106 | CLA Medical Sdn Bhd |
One-Step Test for SARS-CoV-2 Antigen (Colloidal Gold) Self-Test Saliva Sample type: Saliva |
Getein Biotech Inc. P.R.China |
CG20616 CG206162 CG206163 CG206165 CG206166 CG206167 CG206168 CG206169 CG2061610 CG2061612 CG2061615 CG2061620 CG2061625 |
PSC213031W | |
| 107 | RL Healthcare Sdn Bhd |
SARS-CoV-2 Antigen Test Kit (LFIA) Sample type: Nasal swab |
Jiangsu Medomics Medical Technology Co., Ltd. P.R. China |
1031-14-01 | 20210729 | |
| 108 | TOP BIOTECH SDN. BHD. |
COVID-19 Rapid Antigen Home Test Kit (Nasal Swab Specimen) (For Self-Test Use By Non-Professional Users) Sample type: Nasal swab |
TOP BIOTECH SDN BHD 12A, Jalan TP 5, Taman Perindustrian UEP, Subang Jaya, Selangor, Malaysia |
RTB/COVNsl/AG/3.0/A RTB/COVNsl/AG/3.0/B |
TBCV03008101S |
|
| 109 | Rocky Scientific Instrumentation |
SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) – Saliva Swab Sample type: Saliva |
WWHS Biotech.Inc, P.R. China |
044-2-1T 044-2-5T |
4420210814 | |
| 110 | Rocky Scientific Instrumentation |
SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) - Nasal (Anterior) Swab Sample type: Nasal swab |
WWHS Biotech.Inc, P.R. China |
044-1-1T 044-1-5T |
4420210814 | |
| 111 | ANTAH SRI RADIN SDN BHD |
2019-nCoV Antigen Rapid Test Cassette For Self-Testing (Saliva Sample) Sample type: Saliva |
Beijing Applied Biological Technologies Co., Ltd. | CG9041-1T | E20210826 | |
| 112 | Medisafe Technologies Sdn Bhd |
COVICHECK COVID-19 AG SELF TEST Sample type: Saliva |
WIZCHEM CO., LTD. Korea | CAG301S | CAG-20210801 | |
| 113 | Iconic Medicare Sdn Bhd |
COVID-19 Antigen Rapid Test Cassette (Nasal Swab/Oral Fluid) Sample Type: Nasal swab or Oral fluid |
Iconic Medicare Sdn Bhd, Penang, Malaysia. | GCCOV-702a | 2110244 | |
| 114 | Interscience Sdn Bhd |
StrongStep® SARS-CoV-2 Antigen Rapid Test (Self-Test) Sample type: Saliva |
Nanjing Liming Bio-products Co., Ltd. , P.R. China | 500200 | 2108029 | |
| 115 | Rocky Scientific Sdn Bhd |
SARS-CoV-2 Antigen Test Kit (GICA) – Nasal (Anterior) Swab Sample Type: Nasal (Anterior) Swab |
Shenzhen Kisshealth Biotechnology Co., Ltd. P.R.China |
K602-1H, K602-3H, K602-5H | 20210825 | |
| 116 | EB Holding Sdn Bhd |
SARS-CoV-2 Antigen Rapid Test Kit Sample type: Nasal swab |
Xiamen Higia Medical Technology Co., Ltd P.R.China |
XJY01950012 | 21091801 | |
| 117 | Pharmaniaga Marketing Sdn Bhd |
VivaDiag™ SARS-CoV-2 Ag Saliva Rapid Test (Lollipop) Sample type: Saliva |
VivaChek Biotech (Hangzhou) Co., Ltd. P.R China |
VCD17-10-019 | SE2109171 | |
| 118 | RL Healthcare Sdn Bhd, |
SARS - CoV - 2 Antigen Test Kit (LFIA) for Saliva (Type 1)
Sample type: Saliva |
Jiangsu Medomics Medical Technology Co., Ltd. P.R.China | 1031-15-01 | 20210903 | |
| 119 | MAYSTAR BEAUTY SDN BHD |
NeutrovisCOVID-19 Antigen Test Kit (Lateral Chromatography) Sample type: Nasal swab |
H-Guard (China) Co., Ltd. P.R.China | NTV 117 | 20210905 | |
| 120 | MAYSTAR BEAUTY SDN BHD |
NeutrovisCOVID-19 Antigen Test Kit (Lateral Chromatography)
Sample type: Saliva |
H-Guard (China) Co., Ltd. P.R.China | NTV 121 | 20210923 | |
| 121 | Solid Intellectual Sdn Bhd |
COVID-19 Antigen Saliva Test Kit (Colloidal Gold) Sample type: Saliva |
Nantong Diagnos Biotechnology Co., Ltd. P.R.China | DNS COVID-19 - Ag 003 | 202103011 | |
| 122 | HWGB Medical Devices & Supplies Sdn Bhd |
Covid-19 Antigen Saliva Test Kit (Colloidal Gold) Sample type: Saliva |
Bioneovan Co. Ltd. P.R.China |
BG1910C | 20210907 | |
| 123 | RZAC Business Sdn. Bhd. |
HIGHTOP SARS-Cov2 Antigen Rapid Test Sample Type: Nasal swab |
Hightop Biotech Co Ltd. P.R.China |
H100G-23S | COV-1210416 | |
| 124 | Himavant Medic (M) Sdn Bhd |
Mylab CoviSelf Covid-19 Rapid Antigen Test Sample Type: Nasal swab |
Mylab Discovery Solutions Pvt., Ltd., India | MDSC01 | AG00003-A-062101 | |
| 125 | UC Bioscience Sdn Bhd |
Medomics SARS-CoV-2 Antigen Test Kit (LFIA) Sample Type: Nasal swab |
Jiangsu Medomics Medical Technology Co., Ltd.P.R.China |
1031-14-01 1031-34-01 1031-54-01 |
20210729 | |
| 126 | STARVILION SDN BHD |
SARS-CoV-2 Antigen Detection Kit (Saliva) Sample type: Saliva |
Ningbo Lvtang Biotechnology Co., Ltd.P.R. China | JQ-nCovAg-S | NI211003AMY | |
| 127 | Axial Health Sdn Bhd |
Axial Health COVID-19 Saliva Antigen Rapid Test Kit Sample type: Saliva |
Kibaru Manufacturing Sdn Bhd, Kedah Malaysia | V300 (AX-V300) | 20210819 | |
| 128 | Aliya Suria Sdn Bhd |
COVID-19 Antigen Rapid Test Cassette (Saliva)
Sample type: Saliva |
Jiangsu Diagnostics Biotechnology Co.,Ltd, P.R.China | CP023-01 | 20210909002 | |
| 129 | TOP BIOTECH SDN. BHD. |
COVID-19 Rapid Saliva Plus Test Kit
Sample type: Saliva |
TOP BIOTECH SDN BHD, Selangor, Malaysia. |
RTB/COVSlv/AG/3.0/A RTB/COVSlv/AG/3.0/B |
T BCV04030012101NP | |
| 130 | WFR Medical Supplies Sdn Bhd |
COVID-19 SALIVARY ANTIGEN HOME TEST KIT
Sample type: Saliva |
WFR Medical Supplies Sdn Bhd Ltd, Penang Malaysia | WHS-5000 | 5SH2021061504 | |
| 131 | Arterial Global Sdn. Bhd |
SARS-CoV-2 Antigen Rapid Test Cassette Sample type: Saliva |
Merlin Biomedical (Xiamen) Co., Ltd.P.R.China |
CP02140011 CP02150011 |
CG00222208 | |
| 132 | Bumi Genomics Innovation Sdn Bhd |
Innovita 2019-nCoV Ag Test (Latex Chromatography Assay)- Nasal Swab Sample type: Nasal Swab |
Innovita (Tangshan) Biological Technology Co., Ltd. P.R.China | YF320C-NS-HU-1T | 20220202 | |
| 133 | CONAN MEDICAL TECHNOLOGY BERHAD |
SARS-CoV-2 Antigen Rapid Test (Saliva) Sample type: Saliva |
Xiamen Wiz Biotech Co., Ltd. P. R. China |
51432711 (1 test per kit) |
2022011503 | |
| 134 | Neopharma Biotech Asia Sdn Bhd |
SARS-CoV-2 Antigen Saliva Test (For Self-Testing Use) Brand: FASPIT™ Sample type: Saliva |
Atlas Link Technology Co., Ltd., P. R. China | C2112 | 20220309 | |
| 135 | NeoScience Sdn Bhd. |
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antigen Detection Kit (Colloidal Gold-Based) Sample type: Nasal Swab |
Nanjing Vazyme Medical Technology Co., Ltd., P. R. China |
C8611CH C8610CH C8602CH |
V0122011257C | |
| 136 | Reszon Diagnostics International Sdn. Bhd. |
Reszon COVID-19 Rapid Antigen Test (Saliva) Sample type: Saliva |
Reszon Diagnostic International Sdn. Bhd, Kuala Lumpur Malaysia. |
RCV-RD0201S-01 RCV-RD0201S-10 RCV-RD0201S-25 |
202202003 | |
Updated: 12th May 2022