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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: 3-in-1 Rapid Antigen Tests for COVID-19 / Influenza A / Influenza B that are intended for use to differentiate viral infection(s) by COVID-19 / Influenza A / Influenza B
| Listing No.
(HKMD No.) |
Make | Brand, Model | Intended User | Local Responsible Person | Package |
|---|---|---|---|---|---|
| 230160 | Hangzhou AllTest Biotech | SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test (Nasal Swab) (ISIN-525H) | Self-use | LC&P Limited |
Package 1 Package 2 Package 3 Package 4 Package 5 Package 6 Package 7 Package 8 Package 9 Package 10 Package 11 Package 12 Package 13 Package 14 Package 15 Package 16 Package 17 Package 18 |
| 230024 | Xiamen Hopegen Medical Technology | COVID-19 / influenza A virus / influenza B virus Antigen test kit (colloidal gold) (1 test/kit) | Healthcare professional use only | Top Empire International Limited |
Package 1 Package 2 |
Users should carefully read the instructions for use provided by the manufacturer of the 3-in-1 rapid antigen tests when interpret the result and should seek help from medical practitioners when necessary.
Table 2: Rapid Antigen Tests that can be used for self-testing
| 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 Package 4 |
| 230031 | Assure Tech. (Hangzhou) | COVID-19 Antigen Nasal Test Kit (COV-S35002H1, COV-S35002H5, COV-S35002H20) | VAST LEGEND INTERNATIONAL 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 |
| 230029 | Beijing North Institute of Biotechnology | COVID-19 Antigen Rapid Test (RICOV4) | Precision Health Research Center Company Limited |
Package 1 Package 2 |
| 220147 | BGI | SARS-CoV-2 Virus Antigen Detection Kit (colloidal gold method) (MFG030029) | BGI Health (HK) Company Limited | Package |
| 230120 | Biohit Healthcare (Hefei) | BIOUHAN, SARS-CoV-2 Antigen Rapid Test (Colloidal Gold Method), 1 Test/box (209.01.01.01), 2 Tests/box (209.01.02.01), 5 Tests/box (209.01.05.01), 25 Tests/box (209.01.25.01) | Emergo Hong Kong Limited |
Package 1 Package 2 Package 3 Package 4 Package 5 Package 6 Package 7 Package 8 Package 9 Package 10 Package 11 Package 12 Package 13 Package 14 Package 15 |
| 230228 | Biohit Healthcare (HeFei) | BIOUHAN, SARS-CoV-2 Antigen Rapid Test (Colloidal Gold Method) 1 Test/box (209.01.01.01), 2 Tests/box (209.01.02.01) 5 Tests/box (209.01.05.01), 25 Tests/box (209.01.25.01) |
PureMDD Limited |
Package 1 Package 2 Package 3 Package 4 Package 5 Package 6 Package 7 Package 8 Package 9 Package 10 Package 11 Package 12 Package 13 Package 14 Package 15 Package 16 |
| 220107 | Biosynex | Biosynex Autotest Antigenique COVID-19 Ag (859256) | Intuitive Technology Limited | Package |
| 230073 | BioTeke Corporation (Wuxi) | BioTeke SARS-CoV-2 Antigen Test Kit (1 Test/Kit (REF#, TC1002ST1), 3 Tests/Kit (REF#, TC1002ST3), 5 Tests/Kit (REF#, TC1002ST5)) | Milan Pacific Asia Limited |
Package 1 Package 2 Package 3 Package 4 Package 5 Package 6 Package 7 Package 8 Package 9 Package 10 |
| 230003 | BioTeke Corporation (Wuxi) | BioTeke SARS-CoV-2 Antigen Test Kit (1 Test/Kit (REF#, TC1002ST1), 3 Tests/Kit (REF#, TC1002ST3), 5 Tests/Kit (REF#, TC1002ST5)) | Prunus Jade Creation Limited |
Package 1 Package 2 Package 3 Package 4 Package 5 Package 6 Package 7 Package 8 Package 9 Package 10 Package 11 Package 12 |
| 220358 | Core Technology | Coretests, COVID-19 Ag Test | LC&P Limited |
Package 1 Package 2 Package 3 |
| 220348 | Fosun Diagnostics (Shanghai) | Covid-19 Antigen CARD Kit (1.13.0044, 1.13.0045, 1.13.0046) | Lonco Company Limited |
Package 1 Package 2 Package 3 |
| 220321 | Fosun Diagnostics (Shanghai) | Covid-19 Antigen CARD Kit (1.13.0044, 1.13.0045, 1.13.0046) | Silver Lake Trading Limited |
Package 1 Package 2 Package 3 Package 4 Package 5 Package 6 Package 7 |
| 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 |
| 220377 | Hangzhou Aichek Medical Technology | Aichek, COVID-19 Antigen Home Test (COVID-19-G02001B, COVID-19-G02001A, COVID-19-G02005A, COVID-19-G02020A) | Emergo Hong Kong Limited |
Package 1 Package 2 Package 3 Package 4 Package 5 Package 6 Package 7 Package 8 |
| 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 |
| 220347 | Hangzhou Clongene Biotech | Clungene, COVID-19 Antigen Rapid Test (ISCOVu002-B001, ISCOVu002-B005, ISCOVu002-B025) | Sunrise E Tech Company Limited |
Package 1 Package 2 Package 3 |
| 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 |
| 220425 | Hangzhou Sejoy | SARS-CoV-2 Antigen Rapid Test Cassette (COVG-602ST) | Emergo Hong Kong Limited |
Package 1 Package 2 |
| 220413 | Healgen Scientific | Rapid COVID-19 Antigen Self-Test (GCCOV-502a-H1, GCCOV-502a-H2, GCCOV-502a-H3, GCCOV-502a-H5, GCCOV-502a-H7, GCCOV-502a-H10, GCCOV-502a-H15, GCCOV-502a-H20) | Emergo Hong Kong Limited |
Package 1 Package 2 Package 3 Package 4 Package 5 Package 6 Package 7 Package 8 Package 9 Package 10 Package 11 Package 12 Package 13 Package 14 Package 15 Package 16 |
| 230025 | Healgen Scientific | Rapid COVID-19 Antigen Self-Test (GCCOV-502a-H1, GCCOV-502a-H20) | Hytex Medical Technology Limited |
Package 1 Package 2 Package 3 Package 4 |
| 230172 | Huachenyang (Shenzhen) Technology | iClean, COVID-19 Ag Rapid Test Kit (Colloidal Gold) (CY-F006-AG01, CY-F006-AG05, CY-F006-AG25) | Chenyang Global Group Co., Limited |
Package 1 Package 2 Package 3 Package 4 Package 5 Package 6 Package 7 Package 8 |
| 220106 | Jiangsu Medomics Medical Technology | Medomics, SARS CoV-2 Antigen Test Kit (LFIA) (1031-14-01, 1031-34-01, 1031-54-01) | Million Source Limited |
Package 1 Package 2 Package 3 Package 4 Package 5 |
| 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 |
| 230253 | Phase Scientific | INDICAID COVID-19 Rapid Antigen Self-Test (P0079, P0080, P0081, P0082) | Phase Scientific International Limited |
Package 1 Package 2 Package 3 Package 4 |
| 220346 | Pro-med (Beijing) Technology | COVID-19 Antigen Rapid Detection Kit (Colloidal Gold) (PMD-01) | Wing Lee Dispensary Co. Limited |
Package 1 Package 2 Package 3 Package 4 |
| 220016 | SD Biosensor | Roche, SARS-CoV-2 Antigen Self Test Nasal (9901-NCOV-06G) | Roche Diagnostics (Hong Kong) Limited | Package |
| 230046 | Shenzhen Everbest Machinery Industry | COVID-19 Antigen Rapid Test (COV-2200, COV-2201, COV-2202, COV-2203) | STANDARD INSTRUMENTS CO.LTD. |
Package 1 Package 2 Package 3 Package 4 |
| 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 |
| 220365 | Shenzhen Watmind Medical | Aquila Vie Healthcare, SARS-CoV-2 Ag Self-Test Kit (Nasal Swab) (LFA0401-1AE) | Aquila Healthcare Limited |
Package 1 Package 2 Package 3 Package 4 Package 5 |
| 230014 | Shenzhen Watmind Medical | BGI, SARS-CoV-2 Ag Self-test Kit (Nasal Swab) (LFA0401-5AE) | BGI Health (HK) Company Limited |
Package 1 Package 2 Package 3 Package 4 |
| 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 |
| 230028 | Zhuhai Encode Medical Engineering | SARS-CoV-2 Antigen Rapid Test Device (RCD-8021, RCD-8025, RCD-80220) | Milan Pacific Asia Limited |
Package 1 Package 2 Package 3 Package 4 Package 5 Package 6 Package 7 Package 8 |
| 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 Package 3 Package 4 Package 5 Package 6 Package 7 |
Table 3: Rapid Antigen Tests for use by healthcare professional or trained personnel only
| 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 |
| 230251 | Hangzhou Genesis Biodetection and Biocontrol | KaiBiLi COVID-19 Antigen (P211138-1) | BioArrow Technology Limited |
Package 1 Package 2 Package 3 Package 4 |
| 220359 | InTec PRODUCTS | Rapid SARS-CoV-2 Antigen Test (ITP16010-TC1, ITP16010-TC5, ITP16010-TC25) | POTUS Medical (Hong Kong) Limited |
Package 1 Package 2 Package 3 Package 4 Package 5 Package 6 Package 7 |
| 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.
Last update on 12 September 2023
