Senarai Kit Ujian Kendiri COVID-19 Yang Mendapat Kelulusan Bersyarat Daripada Pihak Berkuasa Peranti Perubatan, Kementerian Kesihatan Malaysia

Senarai kit RTK ANTIGEN (Self-Test) yang telah diberikan kelulusan untuk Kelulusan Bersyarat adalah berdasarkan keputusan dalam konsesus Jawatankuasa Pakar Kit Ujian Kendiri Covid-19 adalah seperti berikut.

Semua ujian adalah dinilai berdasarkan:
  • pengilang melaporkan bukti prestasi klinikal dan analisis.
  • keputusan ujian penilaian daripada fasiliti ujian adalah mengikut kriteria penilaian jawatankuasa yang ditetapkan oleh panel pakar Klinikal.
  • Dokumen Sokongan untuk Kit Ujian IVD COVID-19 Kelulusan Bersyarat.
Penggunaan kit ujian kendiri COVID-19 hendaklah dihadkan untuk tujuan saringan sahaja dan semua keputusan ujian memerlukan pengesahan lanjut menggunakan RT-PCR.
Dipaparkan dibawah ialah senarai semua ujian yang telah dipilih setakat ini dan berstatus Kelulusan Bersyarat (sila ambil perhatian: senarai dikemas kini secara rutin).

Nota:
*Jenis sampel adalah berdasarkan laporan penilaian fasiliti ujian.


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This data was published by Medical Device Authority, Ministry of Health Malaysia via https://portal.mda.gov.my/

NOCOMPANY NAMEPRODUCT NAMEMANUFACTURERIDENTIFIERLOT NUMBER
1Reszon Diagnostic International Sdn BhdSalixium-COVID-19 Rapid Antigen Rapid Test (Saliva/ Nasal Swab Samples)Reszon Diagnostics International Sdn Bhd. selangor, MalaysiaSLXHB1-0621001SLXAGl-2105026
Sample type: Saliva and nasal swab samples (Mix Samples)
2Citymedic Sdn BhdGmate® COVID-19 Ag Saliva for Home UsePhilosys Co., Ltd, Republic of KoreaAG-020CSIOUFAO
Sample type: Saliva
3Medinics (M) Sdn BhdBERIGHT-COVID-19 Antigen Rapid Test Device (Oral Fluid)Hangzhou AllTest Biotech Co., Ltd. Zheijang, P.R. ChinaICOV-802HATCOV21060076
Sample type: Saliva
4Neopharma Biotech Asia Sdn BhdJusChek COVID-19 Antigen Rapid Test (Oral Fluid)Hangzhou AllTest Biotech Co., Ltd Zheijang, P.R. China.ICOV-802HATCOV21060078
Sample type: SalivaSample type: Saliva
5Global Science Sdn BhdALLTest COVID-19 Antigen Rapid Test (Oral Fluid)Hangzhou AllTest Biotech Co., Ltd Zheijang, P.R. China.ICOV-802HRATCOV21060077
Sample type: Saliva
6Jingga Anggun Sdn BhdLongsee 2019-nCoV Ag & Influenza A/B Rapid Co-Detection Kit (Immunochromatography) Home based UseGuangdong Longsee Biomedical Co. Ltd.,Guangzhou,P.R. ChinaLS-C-T-005CT005210531
Sample type: Saliva
7Hexamine Sdn BhdSichuan Xincheng (Diacegene) SARS-CoV-2 Antigen AssaySichuan Xincheng Biological Co. Ltd., P.R. China.T4001W521042
8Translab (M) Sdn BhdFlowflex™ SARS-CoV-2 Antigen Rapid Test (Self-testing)ACON Biotech (Hangzhou) Co., Ltd., P.R.ChinaL031-118M5COV1070026
Sample type: Nasal swab
9Neoscience Sdn BhdSTANDARD™ Q COVID-19 Ag Saliva Home TestSD Biosensor, Inc. Republic of KoreaRef No: Q-NCOV-02G Cat. No: 09COV13152D2791AC
Sample type: Saliva
10Medical Innovation Ventures Sdn BhdProDetect™ COVID-19 Antigen Rapid Self-Test (Saliva)Medical Innovation Ventures Sdn Bhd, Penang, MalaysiaPR-CVDCAgSPR-CVDCAgS21JUL09
Sample type: Saliva
11Dewina Consult Sdn BhdNEWGENE Bioengineering COVID-19 Antigen Detection KitNew Gene (Hangzhou) Bioengineering Co., Ltd. P.R. ChinaCOVID-19-NG0820210501-01
Sample type: Saliva, Nasal Swab
12Tree Med Sdn BhdLituo COVID-19 Antigen Detection Kit (Colloidal Gold) Self Test KitZhuhai Lituo Biotechnology Co., Ltd. P. R. ChinaLCV05120210307
Sample type: Saliva
13Pahang Pharmacy Sdn BhdGRUENBANKA SARS-CoV-2 Antigen Detection Kit (Colloidal Gold Method)Ningbo Lvtang Biotechnology Co. Ltd., Zhejiang P.R, China.JQ-nCovAg-SNI21G13BJQ
Sample type: Saliva
14Malaysian Diagnostics Corporation Sdn BhdHumasis COVID-19 Ag Home Test (Self-Test)Humasis Co. Ltd., Republic of Korea.ACOVAGS-7025COVGCF1015
Sample type: Nasal swab
15Teda Wellness Solutions Sdn BhdLYHER® Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold)Hangzhou Laihe Biotech Co. Ltd. Zheijang, P.R. China303062105032
Sample type: Nasal swab
16N.A.Z. Medical Supplies Sdn BhdALLTEST COVID-19 Antigen Rapid TestHangzhou Alltest Biotech Co., Ltd.Hangzhou,P.R.China.ICOV-802HATCOV21070003
(Oral Fluid)
Sample type: Saliva
17Medinics (M) Sdn BhdBeright™ SARS-CoV-2 Antigen Rapid Test (Nasal Swab) For Self-testingHangzhou AllTest Biotech Co.Ltd, P.R China.INCP-502HATNCP21070001
Sample type: Nasal swab
18Roche Diagnostics (M) Sdn BhdRoche SARS-CoV-2 Antigen Self-Test NasalSD Biosensor, Republic of Korea.9901-NCOV-06G / 094453230775822621T1
Sample type: Nasal swab
19Onecare Biotech Sdn BhdARISTA™ COVID-19 Antigen Rapid TestARISTA Biotech Pte. Ltd., Singapore.ARISTA-AG-L1EN-001 ARISTA-AG-L1MY-001405-07006-2106018
Sample type: Nasal swab
20SPD Scientific (M) Sdn BhdWhistling™ Test 2019-nCoV Saliva Ag Easy TestGuangzhou Decheng Biotechnology Co., Ltd, P.R. China.0709D6G001 0709D6G002 0709D6G005 0709D6G010 0709D6G020 0709D6G02570210701
Sample type: Saliva
21Hygeia Instruments (Malaysia) Sdn BhdNewgene Bioengineering COVID-19 Antigen Detection Kit (For Home Self-Use)New Gene (Hangzhou) Bioengineering Co. Ltd., P.R. China.COVID-19-NG0820210721-01
Sample type: Saliva
22Universal Therapeutics Sdn BhdTIB SARS CoV-2 Antigen Rapid Test Kit SalivaTriplex International Biosciences (China) Co., LtdCOV-3S72101
Sample type: Saliva
23Malaysian Diagnostics Corporation Sdn. Bhd.V-check 2019-nCoV Ag Saliva Rapid Test Card (Immunochromatography)Guangdzhou Decheng Biotechnology Co., Ltd., P.R. China.0699C8X00152821022C
0699C8X005
Sample type: Saliva0699C8X020
24Interscience Sdn BhdStrongStep® SARS-CoV-2 Antigen Rapid Test (Self-Test)Nanjing Liming Bio-Products Co. Ltd., P.R. China.5002002108001
Sample type: Nasal swab
25IMP Enterprise Sdn BhdMerlin SARS-CoV-2 Antigen Rapid Test CassetteMerlin Biomedical (Xiamen) Co., Ltd., P.R.China.CP01750011CG00121709
CP01800011
Sample type: Nasal swabCP01760011
26IMP Enterprise Sdn BhdMerlin SARS-CoV-2 Antigen Rapid Test CassetteMerlin Biomedical (Xiamen) Co., Ltd., P.R.China.CP02140011 CP02150011CG00221703
Sample type: Saliva
27Onecare Biotech Sdn BhdLEPU SARS-CoV-2 Antigen Rapid TestBeijing Lepu Medical Technology Co., Ltd., P.R. ChinaCG3601 (1-piece pack)21CG3604F
CG3605 (5-piece pack)
Sample type: Nasal swabCG3610 (10-piece pack)
CG3625 (25-piece pack)
CG3650 (50-piece pack)
28NeoScience Sdn BhdSTANDARD™ Q COVID-19 Ag Home TestSD Biosensor Inc., Republic of KoreaRef No: Q-NCOV-03G58028L1T1
Cat No:
Sample type: Nasal swab09COV130 (1T) 09COV130H (2T)
09COV130J (5T)
09COV130D(25T)
29ExcelMed Sdn BhdSARS-CoV-2 Antigen Detection Kit (Colloidal Gold Method) Home Use Self Test KitXiamen Jiqing Biomedical Technology Co., Ltd., P.R.ChinaWKI0032RI21H17BMY
Sample type: Saliva
30City Medic Sdn BhdWONDFO 2019-nCoV Antigen Test (Lateral Flow Method) Self Test SalivaGuangzhou Wondfo Biotech Co., Ltd. P.R. China.W633P0023,W63310818YZ
Sample type: SalivaW633P0024
31Malaysian Diagnostics Corporation Sdn. Bhd. Lituo COVID-19  Antigen Detection Kit(Colloidal Gold)Zhuhai Lituo Biotechnology, P.R.ChinaLCV0520210402
Sample type: Saliva
32Bles Medic Sdn BhdTigsun COVID-19 Saliva Antigen Rapid TestBeijing Tigsun Diagnostics Co. Ltd., P.R. ChinaTG-1417
Sample type: Saliva14172106
33Universal Therapeutics Sdn BhdNEWGENE COVID-19 Antigen Detection KitNew Gene (Hangzhou) Bioengineering Co. Ltd., P.R. China.NG-082021082001
Sample type: Nasal swab, Saliva
34PMAN Healthcare Specialist Sdn BhdNinonasal® Self-TestNG Biotech Laboratories, FranceNGB-COV-S23-302210305-01-E
Sample type: Nasal swab
35Arterial Global Sdn. BhdSARS-CoV-2 Antigen Rapid Test Cassette (Merlin)Merlin Biomedical (Xiamen) Co., Ltd., P.R.China.REF CP01750011CG00121508
(1 test/kit)
Sample type: Nasal swabREF CP01760011
(20 tests/kit);
REF CP01770011
(50 tests/kit)
REF CP01800011
(1 test/kit);
REF CP01810011
(20 tests/kit
REF CP01820011
(50 tests/kit)
36Gideons (Malaysia) Sdn BhdNovel Coronavirus (2019-nCoV) Antigen Testing Kit (Colloidal Gold)Nanjing Norman Biological Technology Co. Ltd., P.R , ChinaJan-25S2052621
Sample type: Saliva
37XinnerG Sdn Bhd Alltest SARS-CoV-2 Antigen Rapid Test (Nasal swab) for Self-TestingHangzhou AllTest Biotech Co., Ltd., P.R.ChinaINCP-502HATNCP21070012
Sample type: Nasal swab
38Damanyu Healthcare Sdn BhdZosbio 2019-nCoV Ag Rapid Test (Immunochromatography)Zhongxiu Science and Technology Co. Ltd., P.R. China056-B-PD-220210701
Sample type: Nasal swab, Saliva
39Medical Innovation Ventures Sdn.BhdSejoy SARS-CoV-2 Antigen Rapid Test CassetteHangzhou Sejoy Electronics & Instruments Co. Ltd., P.R. ChinaCOVG-602STCOVG210806
Sample type: Saliva
40Medical Innovation Ventures Sdn.BhdWondfo 2019 nCoV Antigen Test (Lateral Flow Method)Guangzhou Wondfo Biotech Co. Ltd., P.R ChinaREF W634P0024,W63410813YZ
Sample type: Nasal swab1 test/kit
REF W634P0028,
2 test/kit
REF W634P0025,
5 test/ kit
41Vquest Sdn BhdTestNGo COVID-19 Rapid Antigen Saliva TestShenzhen Ultra-Diagnostics Biotec Co. Ltd., P.R. ChinaSC023821082106
SARS-CoV-2 Antigen Test Kit (Self-Test)(1 test per pack)
Sample type: SalivaSC0239
(10 test per pack)
SC0225
(20 test per pack)
 42 Malaysian Diagnostics Corporation Sdn. Bhd.CAMTECH COVID-9 Antigen Rapid Self-Test KitCamtech Biomedical Pte Ltd Singapore  RTCSV21070110KS
Sample type: Nasal swab
43Premier Diagnostics Sdn BhdEcotest COVID-19 Antigen Nasal Test KitAssure Tech. (Hangzhou) Co., Ltd. P.R.China.COV-S35002SR2021080003
Sample type: Nasal swab
44Naturmax Sdn BhdHopegene COVID-19 Antigen Rapid Test Kit (Colloidal Gold)Xiamen Hopegen Medical Technology Co. td., P.R ChinaCOVID-19 Antigen Rapid Test Kit (Colloidal Gold) CVD-RTK-SV220210702
Sample type: Saliva
45Jingga Anggun Sdn BhdEmpro Biomed COVID-19 Ag Nasal Self-TestJingga Anggun Sdn. Bhd, MalaysiaSTK-419EBN 20210926
Sample type: Nasal swab
46Conan Medical Technology BerhadWiz Biotech SARS-CoV-2 Antigen Rapid TestXiamen Wiz Biotec Co. Ltd., P.R.China514328012021091704
Sample type: Nasal swab
47Premier Diagnostics Sdn BhdEcotest Covid-19 Antigen Rapid Test Device (Saliva)Assure Tech (Hangzhou) Co. Ltd. P.R. ChinaCOV-S23003I2109080
Sample type: Saliva
48K-One MediTech Sdn BhdLabnovation SARS-CoV-2 Antigen Saliva Rapid Test KitLabnovation Technologies Inc. P.R ChinaLX-40160120210929
Sample type: Saliva
49CTK BIOTECH SDN. BHD.OnSite® COVID-19 Ag Self-TestCTK Biotech Inc. USAR0182CSTRD1930Da
Sample type: Nasal swab
50Malaysian Diagnostics Corporation Sdn BhdNEWGENE COVID-19 Antigen Detection KitNew Gene (Hangzhou) Bioengineering Co., Ltd. P.R. ChinaCOVID-19-NG0820210801-01
Sample type: Nasal swab & Saliva
51 Medinics (M) Sdn BhdBERIGHT SARS-CoV-2 (COVID-19) Antigen Rapid Test Oral Fluid (Saliva)Hangzhou AllTest Biotech Co.Ltd. P.R.ChinaICOV-803HATCOV21080253
Sample type: Saliva
52PETROJESS TRADING SDN BHDARISTA™ COVID-19 Antigen Rapid TestARISTA Biotech Pte. Ltd., SingaporeARISTA-AG-L1EN-001: ARISTA™ COVID-19 Antigen Rapid Test (Self Use) (1 test in single pack)405-07006-2106018
Sample type: Nasal swab & Saliva
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
53ExcelMed Sdn BhdWikang SARS-CoV-2 Antigen Detection Kit (Colloidal Gold Method) Home useXiamen Jiqing Biomedical Technology Co., Ltd. P.R.ChinaWKI0028RI21120BMY
Sample type: Nasal swab
54Convemed Sdn BhdVivaDiag SARS-CoV-2 Ag Rapid TestVivaCheck Biotech (Hangzhou) Co., Ltd. P.R. ChinaVCD05-01-011SE2103063
Sample type: Nasal swab
55EB Holdings Sdn Bhd.SGTi-flex COVID-19 AntigenSugentech INC KoreaCATGT001E0CAGS21001
CATGT002E0
Sample type: Nasal swabCATGT005E0
56Solid Intellectual Sdn BhdNEWGENE COVID-19 Antigen Detection KitNew Gene (Hangzhou) Bioengineering Co., Ltd. P.R. ChinaNG-082021082001
Sample type: Nasal swab & Saliva
57VQM Marketing Sdn BhdALLTEST COVID-19 Antigen Rapid Test (Oral Fluid) For Self TestingHangzhou AllTest Biotech Co., Ltd. P.R.China.ICOV-802HATCOV2080091
Sample type: Saliva
58ScienceVision Sdn BhdRapidFor™ SARS-CoV-2 Saliva Antigen Test Kit (self-testing)Vitrosens Biyoteknoloji Ltd. Sti ,Istanbul TurkeyVSCD05S0521100201
Sample type: Saliva
59B.P. Lab Sdn. Bhd.Singclean COVID-19 Antigen Test Kit (Colloidal Gold)Hangzhou Singclean Medical Products Co., Ltd.P.R.China6.93602E+1259210917A1A
Sample type: Saliva
60Epic Science Sdn. Bhd.Dymind SARS-CoV-2 Antigen Test Kit (Colloidal Gold)Shenzhen Dymind Biotechnology Co., Ltd.P.R.ChinaR0035 20220824
Sample type: SalivaR0037
R0039
61Axial Health Sdn. Bhd.Axial Health COVID-19 Saliva Antigen Rapid Test (Colloid Gold Immunochromatography)WFR Medical Supplies SDN BHD,Penang, MalaysiaAX-V2002021061504
Sample type: Saliva
62Axial Health Sdn. Bhd.Axial Health COVID-19 Salivary Antigen Rapid Test (Colloid Gold Immunochromatography)WFR Medical Supplies SDN BHD,Penang, MalaysiaAX-V1002021061504
Sample type: Saliva
63Medi Diastika Sdn BhdCAS-ENVISION SARS-CoV-2 Antigen Rapid Detection (Self-Test)CAS-Envision Medical Technology  Co., Ltd. P.R.ChinaCG201AW202105001-STY-1
Sample type: Nasal swab & Saliva
64Aureumaex Medicare Marketing (M) Sdn BhdOne Step Test for SARS-CoV-2 Antigen (Colloidal Gold)Getein Biotech Inc. P.R.ChinaCG20615PSC213020W
Sample type: Nasal swabCG206152
CG206153
CG206155
CG206156
CG206157
CG206158
CG206159
CG2061510
CG2061512
CG2061515
CG2061520
CG2061525
 65 Premier Diagnostics Sdn BhdEcotest COVID-19 Antigen Rapid Test Device (Nasal Swab)Assure Tech. (Hangzhou) Co., Ltd.P.R.China CoV-s23004H SR2021080163 
Sample type: Nasal swab
66Premier Diagnostics Sdn BhdSzybio COVID-19 Antigen Rapid Test Kit (Saliva)Wuhan Life Origin Biotech Joint Stock Co., Ltd. P.R.ChinaSF36001C2107023301
Sample type: Saliva
67MEDICAL INNOVATION VENTURES SDN.BHDProDetect™ COVID-19 Antigen Rapid Self-TestMedical Innovation Ventures Sdn. Bhd. Penang,MalaysiaPR-CVDCAgNSPRCVDAgN121AUG04
Sample type: Nasal swab
PR-CVDCAgN1S
PR-CVDCAgN5S
PR-CVDCAgN20S
68Epic Science Sdn. Bhd.Dymind SARS-CoV-2 Antigen Test Kit (Colloidal Gold)Shenzhen Dymind Biotechnology Co., Ltd.P.R.ChinaR00292021082501
Sample type: Nasal swab
R0030
R0034
69ALLIANCE INTEGRITY TRADING SDN. BHDClungene® COVID-19 Antigen Rapid TestHangzhou Clongene Biotech Co., Ltd.P.R.ChinaISCOVu002-700993S202109023
Sample type: Nasal swab
70Convemed Sdn BhdVivaDiagTM SARS-CoV-2 Ag Saliva Rapid TestVivaCheck Biotech (Hangzhou) Co., Ltd.P.R.ChinaVCD17-01-012SE2103162
Sample type: Saliva
71GEOMICO SDN BHDBHM® COVID-19 Antigen Rapid TestBirmingham Biotech Ltd. EnglandBBIO001G2108003
Sample type: Nasal swab
72Global Glades Medic Sdn. Bhd.One Step Test for SARS-CoV-2 Antigen (Colloidal Gold) (Saliva) Test KitGetein Biotech Inc. P.R ChinaCG20616 PSC213031W
Sample type: SalivaCG206162
CG206163
CG206165
CG206166
CG206167
CG206168
CG206169
CG2061610
CG2061612
CG2061615
CG2061620
CG2061625
73Teda Wellness Solutions Sdn BhdRaycus COVID-19 Ag Rapid Test Kit - Saliva self-testingAnhui Raycus Biological Technology Co., Ltd.P.R.ChinaRC2021STC20211001
Sample type: Saliva
74Jingga Anggun Sdn BhdLONGSEE 2019-nCoV Ag Rapid Detection Kit (Immuno-Chromatography)Guangdong Longsee Biomedical Co., Ltd. P.R.ChinaLS-C-T-008CT008210705
Sample type: Saliva
75Rocky Scientific InstrumentationKISSH SARS-CoV-2 Antigen Test Kit (GICA)-SalivaShenzen Kisshealth Biotechnology Co., Ltd.P.R.ChinaK602-1S 20210825
Sample type: SalivaK602-3S
K602-5S
76SPD Scientific (M) Sdn BhdV-Chek 2019-nCoV Antigen Rapid Test Kit (Immunochromatography)Guangzhou Decheng Biotechnology Co., LTD. P.R. China0555C2X00168210701
Sample type: Nasal swab
77XinnerG Sdn BhdGenrui SARS-CoV-2 Antigen Test Kit (Colloidal Gold)Genrui Biotech Inc. P.R. China52104098 (1 test kit)20210618
Sample type: Saliva
52112087 (5 test kit)
52026095 (25 test kit)
78Rapport Medilines Sdn. BhdOne-step Test for SARS-CoV-2 Antigen (Colloidal Gold) (Saliva)Getein Biotech Inc. P.R.ChinaCG20616 PSC213029W
Sample type: SalivaCG206162
CG206163
CG206165
CG206166
CG206167
CG206168
CG206169
CG2061610
CG2061612
CG2061615
CG2061620
CG2061625
79Dyna Source Sdn BhdBioDetect Rapid SARS-CoV-2 Antigen Test Card (Self-test)BioDetect (Xiamen) Biotechnology Co., Ltd. P.R.ChinaGMT102T220050901
Sample type: Nasal swab
80SPD Scientific (M) Sdn. Bhd.Green Spring SARS-CoV-2 Antigen Rapid Test Kit(Colloidal Gold)Shenzhen Lvshiyuan Biotechnology Co., Ltd.P.R.ChinaGF102B1S20210401
Sample type: Nasal swab
81Watercress Communications Sdn BhdeDiagnosis COVID-19 (SARS-CoV-2) Antigen Test KitWuhan EasyDiagnosis Biomedicine Co., Ltd. P.R.ChinaW-AgH-20 (20 test kits) 21070102
Sample type: Nasal swabW-AgH-05S (5 test kits)
W-AgH-01S (1 test kits)
82K-One MediTech Sdn BhdMedkaire SARS-CoV-2 Antigen Kit (Saliva) Self-TestingGoldsite Diagnostics Inc.P.R.ChinaCG12310120210906
Sample type: Saliva
83N.A.Z Medical Supplies Sdn BhdCOVID-19 Salivary Antigen Rapid Test Kit (Colloidal Gold)Jiangsu Konsung Bio-Medical Science and Technology Co., Ltd.P.R.ChinaICOVS-702G-4 S3221072601
Sample type: SalivaICOVS-702G-5
84TS DIAGNOSTICS SDN BHDForsure COVID-19 Antigen Rapid Test Kit (Oral Fluid)TS Diagnostics Sdn Bhd, Taman Perindustrian Puchong, Selangor, Malaysia.FS-CV190F-C302109263
Sample type: Saliva
85Onecare Biotech Sdn BhdHongyu SARS-CoV-2 Rapid Test KitZhejiang Hongyu Medical Commodity Co., Ltd.P.R.ChinaHY-05210820
Sample type: Saliva
86Teda Wellness Solutions Sdn BhdLyher Novel Coronavirus (COVID-19) Antigen Test Kit(Colloidal Gold)Hangzhou Laihe Biotech Co., Ltd. P.R.China3031072108070
Sample type: Saliva
87Multiplex EnterpriseEagle Bio SARS-CoV-2 Antigen IVD Kit Lollipop (Self Testing)Shenzhen Reagent Technology Co., Ltd. P.R.ChinaHN0620210902-01
Sample type: Saliva
88Smarttech Engineering and Resource Management Sdn BhdGenFarm SARS-CoV-2 Antigen Detection KitNingbo Lvtang Biotechnology Co., Ltd. P.R.ChinaCovAg-NS20231017
Sample type: Nasal swab & Saliva
89Symbion Asia Sdn BhdIHealth Novel Coronavirus (SARS-COV-2) Salivary Antigen Rapid Test Kits (Dipstick)Symbion Asia Sdn Bhd, Kuala Lumpur, Malaysia6000011SE2110030
Sample type: Saliva
90Prova Lab & Research Sdn BhdCOVID-19 Ag Rapid Saliva Test DeviceJiangsu Well Biotech Co., Ltd.Cat# CO-03S12108131
Sample type: SalivaP.R.China
91Premier Diagnostics Sdn BhdCOVID-19 Antigen Saliva Test KitAssure Tech. (Hangzhou) Co., Ltd. P.R.China.COV-S35SR2021090090
Sample type: Saliva
92Surgical Solutions (M) Sdn BhdHongyu SARS-CoV-2 Ag Rapid Test KitZhejiang Hongyu Medical Commodity Co., Ltd.HY-05211007
Sample type: SalivaP.R.China
93Innotech Healthcare Sdn BhdCOVID-19 Rapid Antigen Saliva Self-Test Kit (Colloidal Gold)Bioneovan Co., Ltd. P.R. ChinaBG1910C202109003
Sample type: Saliva
94Brands Direct International Sdn BhdSafecare COVID-19 Antigen Rapid Test Kit (Swab) for Self-TestingSafecare Biotech (Hangzhou) Co., LtdCOV AG-6012HCOV21100408
Sample type: Nasal swabP.R.China
95Medical Innovation Ventures Sdn BhdSejoy® SARS-CoV-2 Antigen Saliva Lolly TestHangzhou Sejoy Electronics & Instruments Co., Ltd. P.R.ChinaCOVG-60321102444
Sample type: Saliva
96TT Medical Management Sdn Bhd2019-nCoV Antigen Rapid Test (Saliva) (Colloidal Gold)Xiamen SinaDx Biomedicals Co., Ltd.P.R.ChinaRD0516D12021100801
Sample type: Saliva
97Medispec (M) Sdn BhdSARS-CoV-2 Ag Self-Test Kit (Colloidal Gold)Shenzhen Watmind Medical Co., Ltd. P.R. ChinaLFA0401-1N/5N/25N21100604
Sample type: Saliva
98Medispec (M) Sdn BhdHIGHTOP COVID-19 RTK Antigen Saliva Self-Test (for Home Use)Qingdao HighTop Biotech Co., Ltd.P.R.ChinaH100S-01COV-1210950
Sample type: Saliva
99Amcen Lab Sdn BhdAmTest COVID-19 Antigen Detection Kit (Colloidal Gold)ZHUHAI LITUO BIOTECHNOLOGY CO. LTD P.R. ChinaACV05120210802
Sample type: Saliva
100Y.S.P. INDUSTRIES (M) SDN. BHD.CHEMTRUE® COVID-19 (SARS-CoV-2) Antigen Rapid Test KitShanghai Chemtron Biotech Co., Ltd. P.R.China8046CB202108033
Sample type: Saliva
101Dyna Source Sdn BhdRapid SARS-CoV-2 Antigen Test Card (Saliva)BioDetect (Xiamen) Biotechology Co., Ltd.. P.R.ChinaGMT104T221081101
Sample type: Saliva
102TT Medical Management Sdn BhdKISSH SARS-CoV-2 Antigen Test Kit (GICA) Nasal (Anterior)Shenzhen Kisshealth Biotechnology Co., Ltd. P.R.ChinaK602-1H20210727
Sample type: Nasal swab
103  DW Labs Sdn BhdMEDOMICS SARS-CoV-2 Antigen Test Kit (LFIA) Layman's TestJiangsu Medomics Medical Technology Co., Ltd. P.R.China1031-14-0120210729
Sample type: Nasal swab
104ScienceVision Sdn BhdSARS-CoV-2 Antigen Test Kit (Colloidal Gold)Shenzhen Huian Biosci Technology Co., Ltd. P.R.China203-001 / 203-020211001
Sample type: Saliva
105CLA Medical Sdn BhdOne-Step Test for SARS-CoV-2 Antigen (Colloidal Gold)Getein Biotech Inc. P.R.ChinaCG206156SC216040W
Sample type: Nasal swab
CG206152
CG206153
CG206155
CG206156
CG206157
CG206158
CG206159
CG2061510
CG2061512
CG2061515
CG2061520
CG2061525
106WYS Trading & Management ConsultancyGLINE-2019-nCoV Antigen SalivaShenzhen YHLO Biotech Co., Ltd.P.R.ChinaG86259 (1T)20211001
Sample type: Saliva
107CLA Medical Sdn BhdOne-Step Test for SARS-CoV-2 Antigen (Colloidal Gold) Self-Test SalivaGetein Biotech Inc. P.R.ChinaCG20616PSC213031W
Sample type: Saliva
 CG206162
 CG206163
 CG206165
 CG206166
 CG206167
 CG206168
 CG206169
 CG2061610 CG2061612
CG2061615
 CG2061620
CG2061625
108RL Healthcare Sdn BhdSARS-CoV-2 Antigen Test Kit (LFIA)Jiangsu Medomics Medical Technology Co., Ltd. 1031-14-0120210729
Sample type: Nasal swabP.R. China
109TOP BIOTECH SDN. BHD.COVID-19 Rapid Antigen Home Test Kit (Nasal Swab Specimen) (For Self-Test Use By Non-Professional Users)TOP BIOTECH SDN BHD RTB/COVNsl/AG/3.0/A TBCV03008101S
Sample type: Nasal swab12A, Jalan TP 5, Taman Perindustrian UEP, Subang Jaya, Selangor, MalaysiaRTB/COVNsl/AG/3.0/B
110Rocky Scientific InstrumentationSARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) – Saliva SwabWWHS Biotech.Inc, P.R. China044-2-1T4420210814
Sample type: Saliva044-2-5T
111Rocky Scientific InstrumentationSARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) - Nasal (Anterior) SwabWWHS Biotech.Inc, P.R. China044-1-1T4420210814
Sample type: Nasal swab044-1-5T
112ANTAH SRI RADIN SDN BHD2019-nCoV Antigen Rapid Test Cassette For Self-Testing (Saliva Sample)Beijing Applied Biological Technologies Co., Ltd.CG9041-1TE20210826
Sample type: Saliva
113Innovac Technology Sdn BhdCOVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold)-SalivaAnhui Deepblue Medical Technology Co., Ltd. P.R ChinaSL030101SSTST211003
Sample type: Saliva
114Medisafe Technologies Sdn BhdCOVICHECK COVID-19 AG SELF TESTWIZCHEM CO., LTD. KoreaCAG301SCAG-20210801
Sample type: Saliva
115Iconic Medicare Sdn BhdCOVID-19 Antigen Rapid Test Cassette (Nasal Swab/Oral Fluid)Iconic Medicare Sdn Bhd, Penang, Malaysia.GCCOV-702a2110244
Sample Type: Nasal swab or Oral fluid
116Interscience Sdn BhdStrongStep® SARS-CoV-2 Antigen Rapid Test (Self-Test)Nanjing Liming Bio-products Co., Ltd. , P.R. China5002002108029
Sample type: Saliva
117Rocky Scientific Sdn BhdSARS-CoV-2 Antigen Test Kit (GICA) – Nasal (Anterior) SwabShenzhen Kisshealth Biotechnology Co., Ltd.K602-1H, K602-3H, K602-5H20210825
P.R.China
Sample Type: Nasal (Anterior) Swab
118EB Holding Sdn BhdSARS-CoV-2 Antigen Rapid Test KitXiamen Higia Medical Technology Co., LtdXJY0195001221091801
Sample type: Nasal swabP.R.China
119Pharmaniaga Marketing Sdn BhdVivaDiag™ SARS-CoV-2 Ag Saliva Rapid Test (Lollipop)VivaChek Biotech (Hangzhou) Co., Ltd.VCD17-10-019SE2109171
Sample type: SalivaP.R China
120RL Healthcare Sdn Bhd,SARS - CoV - 2 Antigen Test Kit (LFIA) for Saliva (Type 1)Jiangsu Medomics Medical Technology Co., Ltd. P.R.China1031-15-0120210903
Sample type: Saliva
121MAYSTAR BEAUTY SDN BHDNeutrovisCOVID-19 Antigen Test Kit (Lateral Chromatography)H-Guard (China) Co., Ltd. P.R.ChinaNTV 11720210905
Sample type: Nasal swab
122MAYSTAR BEAUTY SDN BHDNeutrovisCOVID-19 Antigen Test Kit (Lateral Chromatography)H-Guard (China) Co., Ltd. P.R.ChinaNTV 12120210923
Sample type: Saliva
123Solid Intellectual Sdn BhdCOVID-19 Antigen Saliva Test Kit (Colloidal Gold)Nantong Diagnos Biotechnology Co., Ltd. P.R.ChinaDNS COVID-19 - Ag 003202103011
Sample type: Saliva