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.
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.
This data was published by Medical Device Authority, Ministry of Health Malaysia via https://portal.mda.gov.my/
 |
This data was published by Medical Device Authority, Ministry of Health Malaysia via https://portal.mda.gov.my/
| 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) | Reszon Diagnostics International Sdn Bhd. selangor, Malaysia | SLXHB1-0621001 | SLXAGl-2105026 | |
| Sample type: Saliva and nasal swab samples (Mix Samples) | ||||||
| 2 | Citymedic Sdn Bhd | Gmate® COVID-19 Ag Saliva for Home Use | Philosys Co., Ltd, Republic of Korea | AG-020 | CSIOUFAO | |
| Sample type: Saliva | ||||||
| 3 | Medinics (M) Sdn Bhd | BERIGHT-COVID-19 Antigen Rapid Test Device (Oral Fluid) | Hangzhou AllTest Biotech Co., Ltd. Zheijang, P.R. China | ICOV-802H | ATCOV21060076 | |
| Sample type: Saliva | ||||||
| 4 | Neopharma Biotech Asia Sdn Bhd | JusChek COVID-19 Antigen Rapid Test (Oral Fluid) | Hangzhou AllTest Biotech Co., Ltd Zheijang, P.R. China. | ICOV-802H | ATCOV21060078 | |
| Sample type: SalivaSample type: Saliva | ||||||
| 5 | Global Science Sdn Bhd | ALLTest COVID-19 Antigen Rapid Test (Oral Fluid) | Hangzhou AllTest Biotech Co., Ltd Zheijang, P.R. China. | ICOV-802H | RATCOV21060077 | |
| Sample type: Saliva | ||||||
| 6 | Jingga Anggun Sdn Bhd | Longsee 2019-nCoV Ag & Influenza A/B Rapid Co-Detection Kit (Immunochromatography) Home based Use | Guangdong Longsee Biomedical Co. Ltd.,Guangzhou,P.R. China | LS-C-T-005 | CT005210531 | |
| Sample type: Saliva | ||||||
| 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) | ACON Biotech (Hangzhou) Co., Ltd., P.R.China | L031-118M5 | COV1070026 | |
| Sample type: Nasal swab | ||||||
| 9 | Neoscience Sdn Bhd | STANDARD™ Q COVID-19 Ag Saliva Home Test | SD Biosensor, Inc. Republic of Korea | Ref No: Q-NCOV-02G Cat. No: 09COV131 | 52D2791AC | |
| Sample type: Saliva | ||||||
| 10 | Medical Innovation Ventures Sdn Bhd | ProDetect™ COVID-19 Antigen Rapid Self-Test (Saliva) | Medical Innovation Ventures Sdn Bhd, Penang, Malaysia | PR-CVDCAgS | PR-CVDCAgS21JUL09 | |
| Sample type: Saliva | ||||||
| 11 | Dewina Consult Sdn Bhd | NEWGENE Bioengineering COVID-19 Antigen Detection Kit | New Gene (Hangzhou) Bioengineering Co., Ltd. P.R. China | COVID-19-NG08 | 20210501-01 | |
| Sample type: Saliva, Nasal Swab | ||||||
| 12 | Tree Med Sdn Bhd | Lituo COVID-19 Antigen Detection Kit (Colloidal Gold) Self Test Kit | Zhuhai Lituo Biotechnology Co., Ltd. P. R. China | LCV051 | 20210307 | |
| Sample type: Saliva | ||||||
| 13 | Pahang Pharmacy Sdn Bhd | GRUENBANKA SARS-CoV-2 Antigen Detection Kit (Colloidal Gold Method) | Ningbo Lvtang Biotechnology Co. Ltd., Zhejiang P.R, China. | JQ-nCovAg-S | NI21G13BJQ | |
| Sample type: Saliva | ||||||
| 14 | Malaysian Diagnostics Corporation Sdn Bhd | Humasis COVID-19 Ag Home Test (Self-Test) | Humasis Co. Ltd., Republic of Korea. | ACOVAGS-7025 | COVGCF1015 | |
| Sample type: Nasal swab | ||||||
| 15 | Teda Wellness Solutions Sdn Bhd | LYHER® Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold) | Hangzhou Laihe Biotech Co. Ltd. Zheijang, P.R. China | 30306 | 2105032 | |
| Sample type: Nasal swab | ||||||
| 16 | N.A.Z. Medical Supplies Sdn Bhd | ALLTEST COVID-19 Antigen Rapid Test | Hangzhou Alltest Biotech Co., Ltd.Hangzhou,P.R.China. | ICOV-802H | ATCOV21070003 | |
| (Oral Fluid) | ||||||
| Sample type: Saliva | ||||||
| 17 | Medinics (M) Sdn Bhd | Beright™ SARS-CoV-2 Antigen Rapid Test (Nasal Swab) For Self-testing | Hangzhou AllTest Biotech Co.Ltd, P.R China. | INCP-502H | ATNCP21070001 | |
| Sample type: Nasal swab | ||||||
| 18 | Roche Diagnostics (M) Sdn Bhd | Roche SARS-CoV-2 Antigen Self-Test Nasal | SD Biosensor, Republic of Korea. | 9901-NCOV-06G / 09445323077 | 5822621T1 | |
| Sample type: Nasal swab | ||||||
| 19 | Onecare Biotech Sdn Bhd | ARISTA™ COVID-19 Antigen Rapid Test | ARISTA Biotech Pte. Ltd., Singapore. | ARISTA-AG-L1EN-001 ARISTA-AG-L1MY-001 | 405-07006-2106018 | |
| Sample type: Nasal swab | ||||||
| 20 | SPD Scientific (M) Sdn Bhd | Whistling™ Test 2019-nCoV Saliva Ag Easy Test | Guangzhou Decheng Biotechnology Co., Ltd, P.R. China. | 0709D6G001 0709D6G002 0709D6G005 0709D6G010 0709D6G020 0709D6G025 | 70210701 | |
| Sample type: Saliva | ||||||
| 21 | Hygeia Instruments (Malaysia) Sdn Bhd | Newgene Bioengineering COVID-19 Antigen Detection Kit (For Home Self-Use) | New Gene (Hangzhou) Bioengineering Co. Ltd., P.R. China. | COVID-19-NG08 | 20210721-01 | |
| Sample type: Saliva | ||||||
| 22 | Universal Therapeutics Sdn Bhd | TIB SARS CoV-2 Antigen Rapid Test Kit Saliva | Triplex International Biosciences (China) Co., Ltd | COV-3S | 72101 | |
| Sample type: Saliva | ||||||
| 23 | Malaysian Diagnostics Corporation Sdn. Bhd. | V-check 2019-nCoV Ag Saliva Rapid Test Card (Immunochromatography) | Guangdzhou Decheng Biotechnology Co., Ltd., P.R. China. | 0699C8X001 | 52821022C | |
| 0699C8X005 | ||||||
| Sample type: Saliva | 0699C8X020 | |||||
| 24 | Interscience Sdn Bhd | StrongStep® SARS-CoV-2 Antigen Rapid Test (Self-Test) | Nanjing Liming Bio-Products Co. Ltd., P.R. China. | 500200 | 2108001 | |
| Sample type: Nasal swab | ||||||
| 25 | IMP Enterprise Sdn Bhd | Merlin SARS-CoV-2 Antigen Rapid Test Cassette | Merlin Biomedical (Xiamen) Co., Ltd., P.R.China. | CP01750011 | CG00121709 | |
| CP01800011 | ||||||
| Sample type: Nasal swab | CP01760011 | |||||
| 26 | IMP Enterprise Sdn Bhd | Merlin SARS-CoV-2 Antigen Rapid Test Cassette | Merlin Biomedical (Xiamen) Co., Ltd., P.R.China. | CP02140011 CP02150011 | CG00221703 | |
| Sample type: Saliva | ||||||
| 27 | Onecare Biotech Sdn Bhd | LEPU SARS-CoV-2 Antigen Rapid Test | Beijing Lepu Medical Technology Co., Ltd., P.R. China | CG3601 (1-piece pack) | 21CG3604F | |
| CG3605 (5-piece pack) | ||||||
| Sample type: Nasal swab | CG3610 (10-piece pack) | |||||
| CG3625 (25-piece pack) | ||||||
| CG3650 (50-piece pack) | ||||||
| 28 | NeoScience Sdn Bhd | STANDARD™ Q COVID-19 Ag Home Test | SD Biosensor Inc., Republic of Korea | Ref No: Q-NCOV-03G | 58028L1T1 | |
| Cat No: | ||||||
| Sample type: Nasal swab | 09COV130 (1T) 09COV130H (2T) | |||||
| 09COV130J (5T) | ||||||
| 09COV130D(25T) | ||||||
| 29 | ExcelMed Sdn Bhd | SARS-CoV-2 Antigen Detection Kit (Colloidal Gold Method) Home Use Self Test Kit | Xiamen Jiqing Biomedical Technology Co., Ltd., P.R.China | WKI0032 | RI21H17BMY | |
| Sample type: Saliva | ||||||
| 30 | City Medic Sdn Bhd | WONDFO 2019-nCoV Antigen Test (Lateral Flow Method) Self Test Saliva | Guangzhou Wondfo Biotech Co., Ltd. P.R. China. | W633P0023, | W63310818YZ | |
| Sample type: Saliva | W633P0024 | |||||
| 31 | Malaysian Diagnostics Corporation Sdn. Bhd. | Lituo COVID-19 Antigen Detection Kit(Colloidal Gold) | Zhuhai Lituo Biotechnology, P.R.China | LCV05 | 20210402 | |
| Sample type: Saliva | ||||||
| 32 | Bles Medic Sdn Bhd | Tigsun COVID-19 Saliva Antigen Rapid Test | Beijing Tigsun Diagnostics Co. Ltd., P.R. China | TG-1417 | ||
| Sample type: Saliva | 14172106 | |||||
| 33 | Universal Therapeutics Sdn Bhd | NEWGENE COVID-19 Antigen Detection Kit | New Gene (Hangzhou) Bioengineering Co. Ltd., P.R. China. | NG-08 | 2021082001 | |
| Sample type: Nasal swab, Saliva | ||||||
| 34 | PMAN Healthcare Specialist Sdn Bhd | Ninonasal® Self-Test | NG Biotech Laboratories, France | NGB-COV-S23-302 | 210305-01-E | |
| Sample type: Nasal swab | ||||||
| 35 | Arterial Global Sdn. Bhd | SARS-CoV-2 Antigen Rapid Test Cassette (Merlin) | Merlin Biomedical (Xiamen) Co., Ltd., P.R.China. | REF CP01750011 | CG00121508 | |
| (1 test/kit) | ||||||
| Sample type: Nasal swab | 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) | ||||||
| 36 | Gideons (Malaysia) Sdn Bhd | Novel Coronavirus (2019-nCoV) Antigen Testing Kit (Colloidal Gold) | Nanjing Norman Biological Technology Co. Ltd., P.R , China | Jan-25 | S2052621 | |
| Sample type: Saliva | ||||||
| 37 | XinnerG Sdn Bhd | Alltest SARS-CoV-2 Antigen Rapid Test (Nasal swab) for Self-Testing | Hangzhou AllTest Biotech Co., Ltd., P.R.China | INCP-502H | ATNCP21070012 | |
| Sample type: Nasal swab | ||||||
| 38 | Damanyu Healthcare Sdn Bhd | Zosbio 2019-nCoV Ag Rapid Test (Immunochromatography) | Zhongxiu Science and Technology Co. Ltd., P.R. China | 056-B-PD-2 | 20210701 | |
| Sample type: Nasal swab, Saliva | ||||||
| 39 | Medical Innovation Ventures Sdn.Bhd | Sejoy SARS-CoV-2 Antigen Rapid Test Cassette | Hangzhou Sejoy Electronics & Instruments Co. Ltd., P.R. China | COVG-602ST | COVG210806 | |
| Sample type: Saliva | ||||||
| 40 | Medical Innovation Ventures Sdn.Bhd | Wondfo 2019 nCoV Antigen Test (Lateral Flow Method) | Guangzhou Wondfo Biotech Co. Ltd., P.R China | REF W634P0024, | W63410813YZ | |
| Sample type: Nasal swab | 1 test/kit | |||||
| REF W634P0028, | ||||||
| 2 test/kit | ||||||
| REF W634P0025, | ||||||
| 5 test/ kit | ||||||
| 41 | Vquest Sdn Bhd | TestNGo COVID-19 Rapid Antigen Saliva Test | Shenzhen Ultra-Diagnostics Biotec Co. Ltd., P.R. China | SC0238 | 21082106 | |
| SARS-CoV-2 Antigen Test Kit (Self-Test) | (1 test per pack) | |||||
| Sample type: Saliva | SC0239 | |||||
| (10 test per pack) | ||||||
| SC0225 | ||||||
| (20 test per pack) | ||||||
| 42 | Malaysian Diagnostics Corporation Sdn. Bhd. | CAMTECH COVID-9 Antigen Rapid Self-Test Kit | Camtech Biomedical Pte Ltd Singapore | RTCSV | 21070110KS | |
| Sample type: Nasal swab | ||||||
| 43 | Premier Diagnostics Sdn Bhd | Ecotest COVID-19 Antigen Nasal Test Kit | Assure Tech. (Hangzhou) Co., Ltd. P.R.China. | COV-S35002 | SR2021080003 | |
| Sample type: Nasal swab | ||||||
| 44 | Naturmax Sdn Bhd | Hopegene COVID-19 Antigen Rapid Test Kit (Colloidal Gold) | Xiamen Hopegen Medical Technology Co. td., P.R China | COVID-19 Antigen Rapid Test Kit (Colloidal Gold) CVD-RTK-SV | 220210702 | |
| Sample type: Saliva | ||||||
| 45 | Jingga Anggun Sdn Bhd | Empro Biomed COVID-19 Ag Nasal Self-Test | Jingga Anggun Sdn. Bhd, Malaysia | STK-419 | EBN 20210926 | |
| Sample type: Nasal swab | ||||||
| 46 | Conan Medical Technology Berhad | Wiz Biotech SARS-CoV-2 Antigen Rapid Test | Xiamen Wiz Biotec Co. Ltd., P.R.China | 51432801 | 2021091704 | |
| Sample type: Nasal swab | ||||||
| 47 | Premier Diagnostics Sdn Bhd | Ecotest Covid-19 Antigen Rapid Test Device (Saliva) | Assure Tech (Hangzhou) Co. Ltd. P.R. China | COV-S23003 | I2109080 | |
| Sample type: Saliva | ||||||
| 48 | K-One MediTech Sdn Bhd | Labnovation SARS-CoV-2 Antigen Saliva Rapid Test Kit | Labnovation Technologies Inc. P.R China | LX-401601 | 20210929 | |
| Sample type: Saliva | ||||||
| 49 | CTK BIOTECH SDN. BHD. | OnSite® COVID-19 Ag Self-Test | CTK Biotech Inc. USA | R0182CST | RD1930Da | |
| Sample type: Nasal swab | ||||||
| 50 | Malaysian Diagnostics Corporation Sdn Bhd | NEWGENE COVID-19 Antigen Detection Kit | New Gene (Hangzhou) Bioengineering Co., Ltd. P.R. China | COVID-19-NG08 | 20210801-01 | |
| Sample type: Nasal swab & Saliva | ||||||
| 51 | Medinics (M) Sdn Bhd | BERIGHT SARS-CoV-2 (COVID-19) Antigen Rapid Test Oral Fluid (Saliva) | Hangzhou AllTest Biotech Co.Ltd. P.R.China | ICOV-803H | ATCOV21080253 | |
| Sample type: Saliva | ||||||
| 52 | PETROJESS TRADING SDN BHD | ARISTA™ COVID-19 Antigen Rapid Test | ARISTA Biotech Pte. Ltd., Singapore | ARISTA-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 | ||||||
| 53 | ExcelMed Sdn Bhd | Wikang SARS-CoV-2 Antigen Detection Kit (Colloidal Gold Method) Home use | Xiamen Jiqing Biomedical Technology Co., Ltd. P.R.China | WKI0028 | RI21120BMY | |
| Sample type: Nasal swab | ||||||
| 54 | Convemed Sdn Bhd | VivaDiag SARS-CoV-2 Ag Rapid Test | VivaCheck Biotech (Hangzhou) Co., Ltd. P.R. China | VCD05-01-011 | SE2103063 | |
| Sample type: Nasal swab | ||||||
| 55 | EB Holdings Sdn Bhd. | SGTi-flex COVID-19 Antigen | Sugentech INC Korea | CATGT001E0 | CAGS21001 | |
| CATGT002E0 | ||||||
| Sample type: Nasal swab | CATGT005E0 | |||||
| 56 | Solid Intellectual Sdn Bhd | NEWGENE COVID-19 Antigen Detection Kit | New Gene (Hangzhou) Bioengineering Co., Ltd. P.R. China | NG-08 | 2021082001 | |
| Sample type: Nasal swab & Saliva | ||||||
| 57 | VQM Marketing Sdn Bhd | ALLTEST COVID-19 Antigen Rapid Test (Oral Fluid) For Self Testing | Hangzhou AllTest Biotech Co., Ltd. P.R.China. | ICOV-802H | ATCOV2080091 | |
| Sample type: Saliva | ||||||
| 58 | ScienceVision Sdn Bhd | RapidFor™ SARS-CoV-2 Saliva Antigen Test Kit (self-testing) | Vitrosens Biyoteknoloji Ltd. Sti ,Istanbul Turkey | VSCD05 | S0521100201 | |
| Sample type: Saliva | ||||||
| 59 | B.P. Lab Sdn. Bhd. | Singclean COVID-19 Antigen Test Kit (Colloidal Gold) | Hangzhou Singclean Medical Products Co., Ltd.P.R.China | 6.93602E+12 | 59210917A1A | |
| Sample type: Saliva | ||||||
| 60 | Epic Science Sdn. Bhd. | Dymind SARS-CoV-2 Antigen Test Kit (Colloidal Gold) | Shenzhen Dymind Biotechnology Co., Ltd.P.R.China | R0035 | 20220824 | |
| Sample type: Saliva | R0037 | |||||
| R0039 | ||||||
| 61 | Axial Health Sdn. Bhd. | Axial Health COVID-19 Saliva Antigen Rapid Test (Colloid Gold Immunochromatography) | WFR Medical Supplies SDN BHD,Penang, Malaysia | AX-V200 | 2021061504 | |
| Sample type: Saliva | ||||||
| 62 | Axial Health Sdn. Bhd. | Axial Health COVID-19 Salivary Antigen Rapid Test (Colloid Gold Immunochromatography) | WFR Medical Supplies SDN BHD,Penang, Malaysia | AX-V100 | 2021061504 | |
| Sample type: Saliva | ||||||
| 63 | Medi Diastika Sdn Bhd | CAS-ENVISION SARS-CoV-2 Antigen Rapid Detection (Self-Test) | CAS-Envision Medical Technology Co., Ltd. P.R.China | CG201A | W202105001-STY-1 | |
| Sample type: Nasal swab & Saliva | ||||||
| 64 | Aureumaex Medicare Marketing (M) Sdn Bhd | One Step Test for SARS-CoV-2 Antigen (Colloidal Gold) | Getein Biotech Inc. P.R.China | CG20615 | PSC213020W | |
| Sample type: Nasal swab | CG206152 | |||||
| CG206153 | ||||||
| CG206155 | ||||||
| CG206156 | ||||||
| CG206157 | ||||||
| CG206158 | ||||||
| CG206159 | ||||||
| CG2061510 | ||||||
| CG2061512 | ||||||
| CG2061515 | ||||||
| CG2061520 | ||||||
| CG2061525 | ||||||
| 65 | Premier Diagnostics Sdn Bhd | Ecotest COVID-19 Antigen Rapid Test Device (Nasal Swab) | Assure Tech. (Hangzhou) Co., Ltd.P.R.China | CoV-s23004H | SR2021080163 | |
| Sample type: Nasal swab | ||||||
| 66 | Premier Diagnostics Sdn Bhd | Szybio COVID-19 Antigen Rapid Test Kit (Saliva) | Wuhan Life Origin Biotech Joint Stock Co., Ltd. P.R.China | SF36001 | C2107023301 | |
| Sample type: Saliva | ||||||
| 67 | MEDICAL INNOVATION VENTURES SDN.BHD | ProDetect™ COVID-19 Antigen Rapid Self-Test | Medical Innovation Ventures Sdn. Bhd. Penang,Malaysia | PR-CVDCAgNS | PRCVDAgN121AUG04 | |
| Sample type: Nasal swab | ||||||
| PR-CVDCAgN1S | ||||||
| PR-CVDCAgN5S | ||||||
| PR-CVDCAgN20S | ||||||
| 68 | Epic Science Sdn. Bhd. | Dymind SARS-CoV-2 Antigen Test Kit (Colloidal Gold) | Shenzhen Dymind Biotechnology Co., Ltd.P.R.China | R0029 | 2021082501 | |
| Sample type: Nasal swab | ||||||
| R0030 | ||||||
| R0034 | ||||||
| 69 | ALLIANCE INTEGRITY TRADING SDN. BHD | Clungene® COVID-19 Antigen Rapid Test | Hangzhou Clongene Biotech Co., Ltd.P.R.China | ISCOVu002-700993 | S202109023 | |
| Sample type: Nasal swab | ||||||
| 70 | Convemed Sdn Bhd | VivaDiagTM SARS-CoV-2 Ag Saliva Rapid Test | VivaCheck Biotech (Hangzhou) Co., Ltd.P.R.China | VCD17-01-012 | SE2103162 | |
| Sample type: Saliva | ||||||
| 71 | GEOMICO SDN BHD | BHM® COVID-19 Antigen Rapid Test | Birmingham Biotech Ltd. England | BBIO001 | G2108003 | |
| Sample type: Nasal swab | ||||||
| 72 | Global Glades Medic Sdn. Bhd. | One Step Test for SARS-CoV-2 Antigen (Colloidal Gold) (Saliva) Test Kit | Getein Biotech Inc. P.R China | CG20616 | PSC213031W | |
| Sample type: Saliva | CG206162 | |||||
| CG206163 | ||||||
| CG206165 | ||||||
| CG206166 | ||||||
| CG206167 | ||||||
| CG206168 | ||||||
| CG206169 | ||||||
| CG2061610 | ||||||
| CG2061612 | ||||||
| CG2061615 | ||||||
| CG2061620 | ||||||
| CG2061625 | ||||||
| 73 | Teda Wellness Solutions Sdn Bhd | Raycus COVID-19 Ag Rapid Test Kit - Saliva self-testing | Anhui Raycus Biological Technology Co., Ltd.P.R.China | RC2021ST | C20211001 | |
| Sample type: Saliva | ||||||
| 74 | Jingga Anggun Sdn Bhd | LONGSEE 2019-nCoV Ag Rapid Detection Kit (Immuno-Chromatography) | Guangdong Longsee Biomedical Co., Ltd. P.R.China | LS-C-T-008 | CT008210705 | |
| Sample type: Saliva | ||||||
| 75 | Rocky Scientific Instrumentation | KISSH SARS-CoV-2 Antigen Test Kit (GICA)-Saliva | Shenzen Kisshealth Biotechnology Co., Ltd.P.R.China | K602-1S | 20210825 | |
| Sample type: Saliva | K602-3S | |||||
| K602-5S | ||||||
| 76 | SPD Scientific (M) Sdn Bhd | V-Chek 2019-nCoV Antigen Rapid Test Kit (Immunochromatography) | Guangzhou Decheng Biotechnology Co., LTD. P.R. China | 0555C2X001 | 68210701 | |
| Sample type: Nasal swab | ||||||
| 77 | XinnerG Sdn Bhd | Genrui SARS-CoV-2 Antigen Test Kit (Colloidal Gold) | Genrui Biotech Inc. P.R. China | 52104098 (1 test kit) | 20210618 | |
| Sample type: Saliva | ||||||
| 52112087 (5 test kit) | ||||||
| 52026095 (25 test kit) | ||||||
| 78 | Rapport Medilines Sdn. Bhd | One-step Test for SARS-CoV-2 Antigen (Colloidal Gold) (Saliva) | Getein Biotech Inc. P.R.China | CG20616 | PSC213029W | |
| Sample type: Saliva | CG206162 | |||||
| CG206163 | ||||||
| CG206165 | ||||||
| CG206166 | ||||||
| CG206167 | ||||||
| CG206168 | ||||||
| CG206169 | ||||||
| CG2061610 | ||||||
| CG2061612 | ||||||
| CG2061615 | ||||||
| CG2061620 | ||||||
| CG2061625 | ||||||
| 79 | Dyna Source Sdn Bhd | BioDetect Rapid SARS-CoV-2 Antigen Test Card (Self-test) | BioDetect (Xiamen) Biotechnology Co., Ltd. P.R.China | GMT102 | T220050901 | |
| Sample type: Nasal swab | ||||||
| 80 | SPD Scientific (M) Sdn. Bhd. | Green Spring SARS-CoV-2 Antigen Rapid Test Kit(Colloidal Gold) | Shenzhen Lvshiyuan Biotechnology Co., Ltd.P.R.China | GF102B1S | 20210401 | |
| Sample type: Nasal swab | ||||||
| 81 | Watercress Communications Sdn Bhd | eDiagnosis COVID-19 (SARS-CoV-2) Antigen Test Kit | Wuhan EasyDiagnosis Biomedicine Co., Ltd. P.R.China | W-AgH-20 (20 test kits) | 21070102 | |
| Sample type: Nasal swab | W-AgH-05S (5 test kits) | |||||
| W-AgH-01S (1 test kits) | ||||||
| 82 | K-One MediTech Sdn Bhd | Medkaire SARS-CoV-2 Antigen Kit (Saliva) Self-Testing | Goldsite Diagnostics Inc.P.R.China | CG123101 | 20210906 | |
| Sample type: Saliva | ||||||
| 83 | N.A.Z Medical Supplies Sdn Bhd | COVID-19 Salivary Antigen Rapid Test Kit (Colloidal Gold) | Jiangsu Konsung Bio-Medical Science and Technology Co., Ltd.P.R.China | ICOVS-702G-4 | S3221072601 | |
| Sample type: Saliva | ICOVS-702G-5 | |||||
| 84 | 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 | 2109263 | |
| Sample type: Saliva | ||||||
| 85 | Onecare Biotech Sdn Bhd | Hongyu SARS-CoV-2 Rapid Test Kit | Zhejiang Hongyu Medical Commodity Co., Ltd.P.R.China | HY-05 | 210820 | |
| Sample type: Saliva | ||||||
| 86 | Teda Wellness Solutions Sdn Bhd | Lyher Novel Coronavirus (COVID-19) Antigen Test Kit(Colloidal Gold) | Hangzhou Laihe Biotech Co., Ltd. P.R.China | 303107 | 2108070 | |
| Sample type: Saliva | ||||||
| 87 | Multiplex Enterprise | Eagle Bio SARS-CoV-2 Antigen IVD Kit Lollipop (Self Testing) | Shenzhen Reagent Technology Co., Ltd. P.R.China | HN06 | 20210902-01 | |
| Sample type: Saliva | ||||||
| 88 | Smarttech Engineering and Resource Management Sdn Bhd | GenFarm SARS-CoV-2 Antigen Detection Kit | Ningbo Lvtang Biotechnology Co., Ltd. P.R.China | CovAg-NS | 20231017 | |
| Sample type: Nasal swab & Saliva | ||||||
| 89 | Symbion Asia Sdn Bhd | IHealth Novel Coronavirus (SARS-COV-2) Salivary Antigen Rapid Test Kits (Dipstick) | Symbion Asia Sdn Bhd, Kuala Lumpur, Malaysia | 6000011 | SE2110030 | |
| Sample type: Saliva | ||||||
| 90 | Prova Lab & Research Sdn Bhd | COVID-19 Ag Rapid Saliva Test Device | Jiangsu Well Biotech Co., Ltd. | Cat# CO-03S1 | 2108131 | |
| Sample type: Saliva | P.R.China | |||||
| 91 | Premier Diagnostics Sdn Bhd | COVID-19 Antigen Saliva Test Kit | Assure Tech. (Hangzhou) Co., Ltd. P.R.China. | COV-S35 | SR2021090090 | |
| Sample type: Saliva | ||||||
| 92 | Surgical Solutions (M) Sdn Bhd | Hongyu SARS-CoV-2 Ag Rapid Test Kit | Zhejiang Hongyu Medical Commodity Co., Ltd. | HY-05 | 211007 | |
| Sample type: Saliva | P.R.China | |||||
| 93 | Innotech Healthcare Sdn Bhd | COVID-19 Rapid Antigen Saliva Self-Test Kit (Colloidal Gold) | Bioneovan Co., Ltd. P.R. China | BG1910C | 202109003 | |
| Sample type: Saliva | ||||||
| 94 | Brands Direct International Sdn Bhd | Safecare COVID-19 Antigen Rapid Test Kit (Swab) for Self-Testing | Safecare Biotech (Hangzhou) Co., Ltd | COV AG-6012H | COV21100408 | |
| Sample type: Nasal swab | P.R.China | |||||
| 95 | Medical Innovation Ventures Sdn Bhd | Sejoy® SARS-CoV-2 Antigen Saliva Lolly Test | Hangzhou Sejoy Electronics & Instruments Co., Ltd. P.R.China | COVG-603 | 21102444 | |
| Sample type: Saliva | ||||||
| 96 | TT Medical Management Sdn Bhd | 2019-nCoV Antigen Rapid Test (Saliva) (Colloidal Gold) | Xiamen SinaDx Biomedicals Co., Ltd.P.R.China | RD0516D1 | 2021100801 | |
| Sample type: Saliva | ||||||
| 97 | Medispec (M) Sdn Bhd | SARS-CoV-2 Ag Self-Test Kit (Colloidal Gold) | Shenzhen Watmind Medical Co., Ltd. P.R. China | LFA0401-1N/5N/25N | 21100604 | |
| Sample type: Saliva | ||||||
| 98 | Medispec (M) Sdn Bhd | HIGHTOP COVID-19 RTK Antigen Saliva Self-Test (for Home Use) | Qingdao HighTop Biotech Co., Ltd.P.R.China | H100S-01 | COV-1210950 | |
| Sample type: Saliva | ||||||
| 99 | Amcen Lab Sdn Bhd | AmTest COVID-19 Antigen Detection Kit (Colloidal Gold) | ZHUHAI LITUO BIOTECHNOLOGY CO. LTD P.R. China | ACV051 | 20210802 | |
| Sample type: Saliva | ||||||
| 100 | Y.S.P. INDUSTRIES (M) SDN. BHD. | CHEMTRUE® COVID-19 (SARS-CoV-2) Antigen Rapid Test Kit | Shanghai Chemtron Biotech Co., Ltd. P.R.China | 8046C | B202108033 | |
| Sample type: Saliva | ||||||
| 101 | Dyna Source Sdn Bhd | Rapid SARS-CoV-2 Antigen Test Card (Saliva) | BioDetect (Xiamen) Biotechology Co., Ltd.. P.R.China | GMT104 | T221081101 | |
| Sample type: Saliva | ||||||
| 102 | TT Medical Management Sdn Bhd | KISSH SARS-CoV-2 Antigen Test Kit (GICA) Nasal (Anterior) | Shenzhen Kisshealth Biotechnology Co., Ltd. P.R.China | K602-1H | 20210727 | |
| Sample type: Nasal swab | ||||||
| 103 | DW Labs Sdn Bhd | MEDOMICS SARS-CoV-2 Antigen Test Kit (LFIA) Layman's Test | Jiangsu Medomics Medical Technology Co., Ltd. P.R.China | 1031-14-01 | 20210729 | |
| Sample type: Nasal swab | ||||||
| 104 | ScienceVision Sdn Bhd | SARS-CoV-2 Antigen Test Kit (Colloidal Gold) | Shenzhen Huian Biosci Technology Co., Ltd. P.R.China | 203-001 / 203-020 | 211001 | |
| Sample type: Saliva | ||||||
| 105 | CLA Medical Sdn Bhd | One-Step Test for SARS-CoV-2 Antigen (Colloidal Gold) | Getein Biotech Inc. P.R.China | CG20615 | 6SC216040W | |
| Sample type: Nasal swab | ||||||
| CG206152 | ||||||
| CG206153 | ||||||
| CG206155 | ||||||
| CG206156 | ||||||
| CG206157 | ||||||
| CG206158 | ||||||
| CG206159 | ||||||
| CG2061510 | ||||||
| CG2061512 | ||||||
| CG2061515 | ||||||
| CG2061520 | ||||||
| CG2061525 | ||||||
| 106 | WYS Trading & Management Consultancy | GLINE-2019-nCoV Antigen Saliva | Shenzhen YHLO Biotech Co., Ltd.P.R.China | G86259 (1T) | 20211001 | |
| Sample type: Saliva | ||||||
| 107 | CLA Medical Sdn Bhd | One-Step Test for SARS-CoV-2 Antigen (Colloidal Gold) Self-Test Saliva | Getein Biotech Inc. P.R.China | CG20616 | PSC213031W | |
| Sample type: Saliva | ||||||
| CG206162 | ||||||
| CG206163 | ||||||
| CG206165 | ||||||
| CG206166 | ||||||
| CG206167 | ||||||
| CG206168 | ||||||
| CG206169 | ||||||
| CG2061610 CG2061612 | ||||||
| CG2061615 | ||||||
| CG2061620 | ||||||
| CG2061625 | ||||||
| 108 | RL Healthcare Sdn Bhd | SARS-CoV-2 Antigen Test Kit (LFIA) | Jiangsu Medomics Medical Technology Co., Ltd. | 1031-14-01 | 20210729 | |
| Sample type: Nasal swab | P.R. China | |||||
| 109 | TOP 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 swab | 12A, Jalan TP 5, Taman Perindustrian UEP, Subang Jaya, Selangor, Malaysia | RTB/COVNsl/AG/3.0/B | ||||
| 110 | Rocky Scientific Instrumentation | SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) – Saliva Swab | WWHS Biotech.Inc, P.R. China | 044-2-1T | 4420210814 | |
| Sample type: Saliva | 044-2-5T | |||||
| 111 | Rocky Scientific Instrumentation | SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) - Nasal (Anterior) Swab | WWHS Biotech.Inc, P.R. China | 044-1-1T | 4420210814 | |
| Sample type: Nasal swab | 044-1-5T | |||||
| 112 | ANTAH SRI RADIN SDN BHD | 2019-nCoV Antigen Rapid Test Cassette For Self-Testing (Saliva Sample) | Beijing Applied Biological Technologies Co., Ltd. | CG9041-1T | E20210826 | |
| Sample type: Saliva | ||||||
| 113 | Innovac Technology Sdn Bhd | COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold)-Saliva | Anhui Deepblue Medical Technology Co., Ltd. P.R China | SL030101SST | ST211003 | |
| Sample type: Saliva | ||||||
| 114 | Medisafe Technologies Sdn Bhd | COVICHECK COVID-19 AG SELF TEST | WIZCHEM CO., LTD. Korea | CAG301S | CAG-20210801 | |
| Sample type: Saliva | ||||||
| 115 | Iconic Medicare Sdn Bhd | COVID-19 Antigen Rapid Test Cassette (Nasal Swab/Oral Fluid) | Iconic Medicare Sdn Bhd, Penang, Malaysia. | GCCOV-702a | 2110244 | |
| Sample Type: Nasal swab or Oral fluid | ||||||
| 116 | Interscience Sdn Bhd | StrongStep® SARS-CoV-2 Antigen Rapid Test (Self-Test) | Nanjing Liming Bio-products Co., Ltd. , P.R. China | 500200 | 2108029 | |
| Sample type: Saliva | ||||||
| 117 | Rocky Scientific Sdn Bhd | SARS-CoV-2 Antigen Test Kit (GICA) – Nasal (Anterior) Swab | Shenzhen Kisshealth Biotechnology Co., Ltd. | K602-1H, K602-3H, K602-5H | 20210825 | |
| P.R.China | ||||||
| Sample Type: Nasal (Anterior) Swab | ||||||
| 118 | EB Holding Sdn Bhd | SARS-CoV-2 Antigen Rapid Test Kit | Xiamen Higia Medical Technology Co., Ltd | XJY01950012 | 21091801 | |
| Sample type: Nasal swab | P.R.China | |||||
| 119 | Pharmaniaga Marketing Sdn Bhd | VivaDiag™ SARS-CoV-2 Ag Saliva Rapid Test (Lollipop) | VivaChek Biotech (Hangzhou) Co., Ltd. | VCD17-10-019 | SE2109171 | |
| Sample type: Saliva | P.R China | |||||
| 120 | RL Healthcare Sdn Bhd, | SARS - CoV - 2 Antigen Test Kit (LFIA) for Saliva (Type 1) | Jiangsu Medomics Medical Technology Co., Ltd. P.R.China | 1031-15-01 | 20210903 | |
| Sample type: Saliva | ||||||
| 121 | MAYSTAR BEAUTY SDN BHD | NeutrovisCOVID-19 Antigen Test Kit (Lateral Chromatography) | H-Guard (China) Co., Ltd. P.R.China | NTV 117 | 20210905 | |
| Sample type: Nasal swab | ||||||
| 122 | MAYSTAR BEAUTY SDN BHD | NeutrovisCOVID-19 Antigen Test Kit (Lateral Chromatography) | H-Guard (China) Co., Ltd. P.R.China | NTV 121 | 20210923 | |
| Sample type: Saliva | ||||||
| 123 | Solid Intellectual Sdn Bhd | COVID-19 Antigen Saliva Test Kit (Colloidal Gold) | Nantong Diagnos Biotechnology Co., Ltd. P.R.China | DNS COVID-19 - Ag 003 | 202103011 | |
| Sample type: Saliva |