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
Make Brand Model Local Responsible Person Package
Abbott Rapid Diagnostics   Panbio COVID-19 Antigen Self-Test (41FK51, 41FK71, 41FK81, 41FK91) Abbott Laboratories Limited Package 1
Package 2
Package 3
Package 4
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
AESKU.Diagnostics   AESKU.RAPID SARS-CoV-2 (840005E, 840003E, 840001E) POTUS Medical (Hong Kong) Limited Package 1
Package 2
Package 3
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
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
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
BGI   SARS-CoV-2 Virus Antigen Detection Kit (colloidal gold method) (MFG030029) BGI Health (HK) Company Limited Package
Biosynex   Biosynex Autotest Antigenique COVID-19 Ag (859256) Intuitive Technology Limited Package
Hangzhou Biotest Biotech RightSign COVID-19 Antigen Rapid Test Cassette (Nasal Swab) (ICOVN-C81H) Seekers Biomedical Limited Package
Hangzhou Clongene Biotech CLUNGENE COVID-19 Antigen Rapid Test (ISCOVu002-B001, ISCOVu002-B005) Wittis Smart Technology Limited Package 1
Package 2
Hangzhou Sejoy   SARS-CoV-2 Antigen Rapid Test Cassette (COVG-602ST) Continental Supplies Ltd. Package
Jiangsu Medomics Medical Technology Medomics SARS CoV-2 Antigen Test Kit (LFIA) (1031-14-01) Million Source Limited Package
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
SD Biosensor Roche SARS-CoV-2 Antigen Self Test Nasal (9901-NCOV-06G) Roche Diagnostics (Hong Kong) Limited Package
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
Shenzhen YHLO Biotech YHLO GLINE-2019-nCoV Ag (G86256, G86257, G86278, G86279, G86280, G86273, G86281) Hong Kong (International) Eye Care Group Limited Package
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
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

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

Listed Rapid Antigen Tests for COVID-19
Make Brand Model Local Responsible Person Package
AESKU.Diagnostics   AESKU.RAPID SARS-CoV-2 (840001, 840003, 840005) Potus Medical (Hong Kong) Limited Package 1
Package 2
Package 3
BGI   SARS-CoV-2 Virus Antigen Detection Kit (colloidal gold method) (MFG030026) BGI Health (HK) Company Limited Package
Hangzhou AllTest Biotech ALLTest SARS-CoV-2 Antigen Rapid Test (Nasal Swab) (INCP-502-N) Emergo Hong Kong Limited Package
Hangzhou AllTest Biotech FIATest COVID-19 Antigen Test Cassette (Nasopharyngeal Swab) (FI-NCP-502) Emergo Hong Kong Limited Package
Phase Scientific   INDICAID COVID-19 Rapid Antigen Test Phase Scientific International Limited Package
Sanwa BioTech Limited   CO-Check COVID-19 Rapid Antigen Test (5314-01, 5314-20) Sanwa BioTech Limited Package 1
Package 2
Package 3
Sanwa BioTech Limited   CO-Check SARS-CoV-2 Antigen LFIA Test (5311-01) Sanwa BioTech Limited Package 1
Package 2
SD Biosensor Roche SARS-CoV-2 Rapid Antigen Test Nasal (9901-NCOV-03G) Roche Diagnostics (Hong Kong) Limited Package

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 16 May 2022