Listed Rapid Antigen Tests for COVID-19 under MDACS

Listed Rapid Antigen Tests for COVID-19 under MDACS

The Medical Device Division (MDD) has granted listing approval for the following rapid antigen tests for COVID-19. All the listed devices meet the listing requirements of Medical Device Administrative Control System (MDACS) on safety, quality and performance. Department of Health also monitors the safety alerts issued by oversea regulatory authorities and manufacturers, and handles adverse events associated with devices listed under MDACS.

Details of listed rapid antigen tests for COVID-19 can be found in The List of Medical Devices.

Table 1: Rapid Antigen Tests that can be used for self-testing

Listed Rapid Antigen Tests for COVID-19
Listing No.
(HKMD No.)
Make Brand, Model Local Responsible Person Package
220019 Abbott Rapid Diagnostics Panbio COVID-19 Antigen Self-Test (41FK51, 41FK71, 41FK81, 41FK91) Abbott Laboratories Limited Package 1
Package 2
Package 3
Package 4
220072 Acon Biotech (Hangzhou) Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) (L031-118M5, L031-118P5, L031-118R5) Prenetics Limited Package 1
Package 2
Package 3
220152 AESKU.Diagnostics AESKU.RAPID SARS-CoV-2 (840005E, 840003E, 840001E) POTUS Medical (Hong Kong) Limited Package 1
Package 2
Package 3
220243 AmonMed COVID-19 Antigen Rapid Test Kit (Colloidal Gold) (CG01Ag-01S-ST, CG01Ag-05S-ST, CG01Ag-25S-ST) Aviton Care Limited Package 1
Package 2
Package 3
Package 4
220245 Anbio (Xiamen) Biotechnology Skypro, Rapid COVID-19 Antigen Test (Colloidal Gold)/ Nasal Swab (A606101) Skypro Medical Supplies Company Limited Package 1
Package 2
220120 Anhui Deepblue Medical Technology Savewo, COVID-19(SARS-CoV-2) Antigen Test Kit (Colloidal Gold) (SL030101NST-1, SL030101NST-20, SL030101NST-25) Savewo Distribution Limited Package 1
Package 2
Package 3
220102 Beijing Hotgen Biotech Coronavirus (2019-nCoV)-Antigentest- (HGCG134S0101, HGCG134S0105, HGCG134S0120, HGCG134S0140) Hotgen Biotech Hong Kong Private Limited Package 1
Package 2
Package 3
Package 4
Package 5
220073 Beijing Lepu Medical Technology SARS-CoV-2 Antigen Rapid Test Kits for Self-testing (Colloidal Gold Immunochromatography) (CG3601, CG3605, CG3610, CG3625, CG3650) Pacific Medical (Hong Kong) Company Limited Package 1
Package 2
Package 3
Package 4
220147 BGI SARS-CoV-2 Virus Antigen Detection Kit (colloidal gold method) (MFG030029) BGI Health (HK) Company Limited Package
220107 Biosynex Biosynex Autotest Antigenique COVID-19 Ag (859256) Intuitive Technology Limited Package
220222 GETEIN Biotech One Step Test for SARS-CoV-2 Antigen (Colloidal Gold) (CG20615) I AlphaMed Limited Package
220286 Guangdong Hecin Hecin, 2019-nCoV Antigen Test Kit (colloidal gold method) (JT11-1) Lonco Company Limited Package 1
Package 2
Package 3
220287 Guangdong Hecin Hecin, 2019-nCoV Antigen Test Kit (colloidal gold method) (JT11-1, JT11-5, JT11-20) Fayeking Technology Limited Package 1
Package 2
Package 3
Package 4
220285 Guangzhou Wondfo Wondfo, Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) (W634P0024, W634P0025, W634P0026, W634P0027, W634P0028) Wondfo Biotech (HK) Co., Limited Package 1
Package 2
Package 3
Package 4
Package 5
Package 6
220122 Hangzhou Biotest Biotech RightSign, COVID-19 Antigen Rapid Test Cassette (Nasal Swab) (ICOVN-C81H) Seekers Biomedical Limited Package
220145 Hangzhou Clongene Biotech CLUNGENE, COVID-19 Antigen Rapid Test (ISCOVu002-B001, ISCOVu002-B005) Wittis Smart Technology Limited Package 1
Package 2
220200 Hangzhou Realy Tech Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (nasal swab) (K601416D) Sincere Top International Limited Package
220108 Hangzhou Sejoy SARS-CoV-2 Antigen Rapid Test Cassette (COVG-602ST) Continental Supplies Ltd. Package
220106 Jiangsu Medomics Medical Technology Medomics, SARS CoV-2 Antigen Test Kit (LFIA) (1031-14-01) Million Source Limited Package
220146 Labnovation SARS-CoV-2 Antigen Rapid Test Kit (LX-401302, LX-401305, LX-401320) Clearbridge Medical Hong Kong Corporation Limited Package 1
Package 2
Package 3
220016 SD Biosensor Roche, SARS-CoV-2 Antigen Self Test Nasal (9901-NCOV-06G) Roche Diagnostics (Hong Kong) Limited Package
220210 Shenzhen Microprofit Biotech fluorecare, SARS-CoV-2 Antigen Test Kit (Colloidal Gold Chromatographic Immunoassay) (MF-68) Shan Ho Asia Pacific Limited Package 1
Package 2
Package 3
Package 4
Package 5
220148 Shenzhen YHLO Biotech YHLO, GLINE-2019-nCoV Ag (G86256, G86257, G86278, G86279, G86280, G86273, G86281) BGI Health (HK) Company Limited Package 1
Package 2
Package 3
Package 4
Package 5
Package 6
Package 7
220103 Shenzhen YHLO Biotech YHLO, GLINE-2019-nCoV Ag (G86256, G86257, G86278, G86279, G86280, G86273, G86281) Hong Kong (International) Eye Care Group Limited Package
220109 VivaChek Biotech (Hangzhou) Verino Pro SARS-CoV-2 Ag Rapid Test (VCD16-10-043, VCD16-10-044, VCD16-10-041) AccuMed Limited Package 1
Package 2
Package 3
220159 Zhuhai Encode Medical Engineering SARS-CoV-2 Antigen Rapid Test Device (RCD-8021, RCD-8025, RCD-80220) Dajiang Technology Holdings Limited Package 1
Package 2
Package 3
220194 Zybio SARS-CoV-2 Antigen Assay Kit (Collodial Gold Method) (2061703, 2061704, 2061702) Capsule Enterprise Company Limited Package 1
Package 2
220193 Zybio SARS-CoV-2 Antigen Assay Kit (Collodial Gold Method) (2061703, 2061704, 2061702) Visual Link Company Limited Package 1
Package 2

Table 2: Rapid Antigen Tests for use by healthcare professional or trained personnel only

Listed Rapid Antigen Tests for COVID-19
Listing No.
(HKMD No.)
Make Brand, Model Local Responsible Person Package
220070 AESKU.Diagnostics AESKU.RAPID SARS-CoV-2 (840001, 840003, 840005) Potus Medical (Hong Kong) Limited Package 1
Package 2
Package 3
220169 Beijing Kewei Clinical Diagnostic Reagent COVID-19 Antigen Rapid Test Kit (601460) AUISET Health Limited Package 1
Package 2
220176 Beijing North Institute of Biotechnology COVID-19 Antigen Rapid Test Precision Health Research Center Company Limited Package 1
Package 2
220042 BGI SARS-CoV-2 Virus Antigen Detection Kit (colloidal gold method) (MFG030026) BGI Health (HK) Company Limited Package
220196 Fosun Diagnostics (Shanghai) Fosun Covid-19 Ag CARD Silver Lake Trading Limited Package 1
Package 2
Package 3
220017 Hangzhou AllTest Biotech ALLTest, SARS-CoV-2 Antigen Rapid Test (Nasal Swab) (INCP-502-N) Emergo Hong Kong Limited Package
220018 Hangzhou AllTest Biotech FIATest, COVID-19 Antigen Test Cassette (Nasopharyngeal Swab) (FI-NCP-502) Emergo Hong Kong Limited Package
220071 Phase Scientific INDICAID COVID-19 Rapid Antigen Test Phase Scientific International Limited Package
220080 Sanwa BioTech CO-Check COVID-19 Rapid Antigen Test (5314-01, 5314-20) Sanwa BioTech Limited Package 1
Package 2
Package 3
220081 Sanwa BioTech CO-Check SARS-CoV-2 Antigen LFIA Test (5311-01) Sanwa BioTech Limited Package 1
Package 2
220015 SD Biosensor Roche, SARS-CoV-2 Rapid Antigen Test Nasal (9901-NCOV-03G) Roche Diagnostics (Hong Kong) Limited Package
220223 Xiamen AmonMed Biotechnology COVID-19 Antigen Rapid Test Kit (Colloidal gold) (CG01Ag-01, CG01Ag-25) Top Empire International Limited Package 1
Package 2

Furthermore, in the page of Rapid Antigen Tests under COVID-19 Thematic Website, the Government also provides lists of rapid antigen tests of regulatory authorities such as Listed Rapid Antigen Tests for COVID-19 under MDACS, National Medical Products Administration, European Union and U.S. Food and Drug Administration and the details of rapid antigen tests recently procured by the Government for free distribution to targeted groups as references for the members of the public during purchase. For details, please refer to the COVID-19 Thematic Website.

More:
Public Education On Rapid Antigen Test For COVID-19Public Education On Rapid Antigen Test For COVID-19Safety Alerts & Special Alerts Related To COVID-19 Medical DevicesSafety Alerts & Special Alerts Related To COVID-19 Medical DevicesTraders' Corner: Application For Listing Of Rapid Antigen Test Under MDACSTraders' Corner: Application For Listing Of Rapid Antigen Test Under MDACS


Last update on 26 September 2022