More:
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 has always been closely monitoring safety alerts of medical device issued by other regulatory jurisdictions as well as the World Health Organization, under the established mechanism, 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: Combination rapid antigen tests for COVID-19 and other pathogens that are intended for use to differentiate viral infection(s)
| Listing No. (HKMD No.) |
Manufacturer | Brand Name and Model | Intended User | Local Responsible Person | Package |
|---|---|---|---|---|---|
| 230160 | Hangzhou AllTest Biotech Co., Ltd. | 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 |
| 240133 | Hangzhou Fanttest Biotech Co., Ltd. | COVID-19/Influenza A&B Antigen Test Kit (1 Test/Kit, 5 Tests/Kit, 20 Tests/Kit, 25 Tests/Kit) | Self-use | Top Biological Technology Limited |
Package 1 Package 2 Package 3 Package 4 Package 5 Package 6 Package 7 Package 8 |
| 240361 | Hangzhou Fanttest Biotech Co., Ltd. | Fanttest COVID-19/RSV/Influenza A&B Antigen Rapid Test Kit (1 Test/Kit, 5 Tests/Kit) | Self-use | AccuMed Limited |
Package 1 Package 2 |
| 240333 | Hangzhou Fanttest Biotech Co., Ltd. | Fanttest COVID-19/RSV/Influenza A&B Antigen Rapid Test Kit (1 Test/Kit, 5 Tests/Kit, 20 Tests/Kit, 25 Tests/Kit) | Self-use | Top Biological Technology Limited |
Package 1 Package 2 Package 3 Package 4 |
| 240334 | Hangzhou Fanttest Biotech Co., Ltd. | Diagfest COVID-19/RSV/Influenza A&B Antigen Rapid Test Kit (1 Test/Kit, 5 Tests/Kit, 20 Tests/Kit, 25 Tests/Kit) | Self-use | Top Biological Technology Limited |
Package 1 Package 2 Package 3 Package 4 |
| 230344 | Hangzhou Heo Technology Co., Ltd. | Heo Technology, COVID-19/lnfluenza A+B Antigen Combo Rapid Test Cassette (010027, 010028) | Self-use | AccuMed Limited |
Package 1 Package 2 |
| 240148 | Jiangsu Medomics Medical Technology Co. Ltd | Medomics SARS Cov-2 & Influenza A/B Antigen Combo Rapid Test Kit (LFIA) (1041-14-01, 1041-24-01, 1041-34-01, 1041-54-01) | Self-use | Million Source Limited |
Package 1 Package 2 Package 3 Package 4 |
| 230024 | Xiamen Hopegen Medical Technology Co., Ltd | 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 combination 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.) |
Manufacturer | Brand Name and Model | Local Responsible Person | Package |
|---|---|---|---|---|
| 220019 | Abbott Rapid Diagnostics Jena GmbH | Panbio COVID-19 Antigen Self-Test (41FK51, 41FK71, 41FK81, 41FK91) | Abbott Laboratories Limited | Package 1
Package 2 Package 3 Package 4 |
| 220152 | AESKU.Diagnostics GmbH & Co. KG | AESKU.RAPID SARS-CoV-2 (840005E, 840003E, 840001E) | POTUS Medical (Hong Kong) Limited | Package 1
Package 2 Package 3 |
| 220243 | Xiamen AmonMed Biotechnology Co., Ltd | 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 Co., Ltd. | 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 Co., Ltd. | 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) Co., Ltd | 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 Co., Ltd. | 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 Co., Ltd | 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 Co., Ltd. | COVID-19 Antigen Rapid Test (RICOV4) | Precision Health Research Center Company Limited |
Package 1 Package 2 |
| 230228 | Biohit Healthcare (HeFei) Co.,Ltd | 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 SWISS SA | Biosynex Autotest Antigenique COVID-19 Ag (859256) | Intuitive Technology Limited | Package |
| 230073 | BioTeke Corporation (Wuxi) Co., Ltd. | 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 |
| 220348 | Fosun Diagnostics (Shanghai) Co., Ltd. | 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) Co., Ltd. | 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 |
| 220286 | Guangdong Hecin Scientific, Inc. | Hecin, 2019-nCoV Antigen Test Kit (colloidal gold method) (JT11-1) | Lonco Company Limited |
Package 1 Package 2 Package 3 |
| 220287 | Guangdong Hecin Scientific, Inc. | 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 Biotech Co., Ltd. | 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 Co., Ltd. | 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 Co., Ltd | RightSign, COVID-19 Antigen Rapid Test Cassette (Nasal Swab) (ICOVN-C81H) | Seekers Biomedical Limited | Package |
| 220145 | Hangzhou Clongene Biotech Co., Ltd. | CLUNGENE, COVID-19 Antigen Rapid Test (ISCOVu002-B001, ISCOVu002-B005) | Wittis Smart Technology Limited | Package 1
Package 2 |
| 220347 | Hangzhou Clongene Biotech Co., Ltd. | 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 Co., Ltd. | Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (nasal swab) (K601416D) | Sincere Top International Limited | Package |
| 230452 | Hangzhou Realy Tech Co., Ltd. | SARS-Cov-2 & Influenza A/B Combo Rapid Test Cassette (swab) (K751416D) | Sincere Top International Limited |
Package 1 Package 2 Package 3 |
| 220108 | Hangzhou Sejoy Electronics & Instruments Co., Ltd | SARS-CoV-2 Antigen Rapid Test Cassette (COVG-602ST) | Continental Supplies Ltd. | Package |
| 220425 | Hangzhou Sejoy Electronics & Instruments Co., Ltd. | SARS-CoV-2 Antigen Rapid Test Cassette (COVG-602ST) | Emergo Hong Kong Limited |
Package 1 Package 2 |
| 220413 | Healgen Scientific Limited Liability Company | 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) | 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 |
| 230025 | Healgen Scientific Limited Liability Company | 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 Co., Ltd. | 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 Co. Ltd. | 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 Technologies, Inc. | 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 |
| 230433 | Nanjing Synthgene Medical Technology Co., Ltd. | Synthgene, SARS-CoV-2 Nucleocapsid (N) Antigen Rapid Detection Kit (Colloidal Gold method) (RQ00501001HK, RQ00501002HK, RQ00501003HK, RQ00501005HK, RQ00501006HK, RQ00501007HK, RQ00501008HK, RQ00501009HK, RQ00501010HK, RQ00501012HK, RQ00501015HK, RQ00501020HK, RQ00501025HK, RQ00501030HK, RQ00501050HK) | Wanwu (Hong Kong) Biotechnology Co., 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 |
| 230401 | Ningbo Lvtang Biotechnology Co., Ltd | SARS-CoV-2 Antigen Detection Kit (Colloidal Gold Method) (CovAg-N-1, CovAg-N-2, CovAg-N-5, CovAg-N-20, CovAg-N-25) | RK Direct Trading Limited |
Package 1 Package 2 Package 3 Package 4 Package 5 |
| 220346 | Pro-med (Beijing) Technology Co., Ltd. | COVID-19 Antigen Rapid Detection Kit (Colloidal Gold) (PMD-01) | Wing Lee Dispensary Co. Limited |
Package 1 Package 2 Package 3 Package 4 |
| 230367 | Sansure Biotech Inc. | SARS-CoV-2 Rapid Antigen Test (lmmunochromatography Assay) (S3120E-1-H, S3120E-5-H) | Inresearch Medical Limited |
Package 1 Package 2 Package 3 Package 4 Package 5 Package 6 Package 7 Package 8 Package 9 |
| 230046 | Shenzhen Everbest Machinery Industry Co., Ltd. | 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 Co., Ltd | 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 Co., Ltd | 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 Co., Ltd | 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 Co., Ltd | 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 Co., Ltd | YHLO, GLINE-2019-nCoV Ag (G86256, G86257, G86278, G86279, G86280, G86273, G86281) | Hong Kong (International) Eye Care Group Limited | Package |
| 220109 | VivaChek Biotech (Hangzhou) Co., Ltd. | 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 |
| 230333 | Xiamen Biotime Biotechnology Co., Ltd. | Handytest, SARS-CoV-2 Antigen Rapid Qualitative Test (For type A: 1 test/pouch, 1 test/kit, 3 tests/kit, 5 tests/kit, 7 tests/kit, 20 tests/kit, 25 tests/kit, 50 tests/kit, 100 tests/kit. For type B: 1 test/pouch, 1 test/kit, 3 tests/kit, 5 tests/kit, 7 tests/kit, 20 tests/kit, 25 tests/kit, 50 tests/kit, 100 tests/kit.) |
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 |
| 230343 | Zhejiang Orient Gene Biotech Co., Ltd. | Orient Gene, Rapid COVID-19 (Antigen) Self-Test (GCCOV-502a-H1OGE, GCCOV-502a-H2OGE, GCCOV-502a-H3OGE, GCCOV-502a-H5OGE, GCCOV-502a-H10OGE, GCCOV-502a-H15OGE, GCCOV-502a-H20OGE, GCCOV-502a-H25OGE) | 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 |
| 220159 | Zhuhai Encode Medical Engineering Co., LTD | 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 Co., Ltd | 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 Inc. | SARS-CoV-2 Antigen Assay Kit (Collodial Gold Method) (2061703, 2061704, 2061702) | Capsule Enterprise Company Limited | Package 1
Package 2 |
Table 3: Rapid Antigen Tests for use by healthcare professional or trained personnel only
| Listing No. (HKMD No.) |
Manufacturer | Brand Name and Model | Local Responsible Person | Package |
|---|---|---|---|---|
| 220070 | AESKU.Diagnostics GmbH & Co. KG | 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 Inc. | COVID-19 Antigen Rapid Test Kit (601460) | AUISET Health Limited | Package 1
Package 2 |
| 220176 | Beijing North Institute of Biotechnology Co., Ltd. | COVID-19 Antigen Rapid Test | Precision Health Research Center Company Limited | Package 1
Package 2 |
| 220042 | BGI Europe A/S | SARS-CoV-2 Virus Antigen Detection Kit (colloidal gold method) (MFG030026) | BGI Health (HK) Company Limited |
Package 1 Package 2 Package 3 Package 4 Package 5 |
| 220196 | Fosun Diagnostics (Shanghai) Co., Ltd | Fosun Covid-19 Ag CARD | Silver Lake Trading Limited | Package 1
Package 2 Package 3 |
| 220017 | Hangzhou AllTest Biotech Co., Ltd. | ALLTest, SARS-CoV-2 Antigen Rapid Test (Nasal Swab) (INCP-502-N) | Emergo Hong Kong Limited | Package |
| 220018 | Hangzhou AllTest Biotech Co., Ltd. | FIATest, COVID-19 Antigen Test Cassette (Nasopharyngeal Swab) (FI-NCP-502) | Emergo Hong Kong Limited | Package |
| 230251 | Hangzhou Genesis Biodetection and Biocontrol Co., Ltd. | KaiBiLi COVID-19 Antigen (P211138-1) | BioArrow Technology Limited |
Package 1 Package 2 Package 3 Package 4 |
| 220359 | InTec PRODUCTS, INC. | 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 International Limited | INDICAID COVID-19 Rapid Antigen Test | Phase Scientific International Limited | Package |
| 220080 | Sanwa BioTech Limited | CO-Check COVID-19 Rapid Antigen Test (5314-01, 5314-20) | Sanwa BioTech Limited | Package 1
Package 2 Package 3 |
| 220081 | Sanwa BioTech Limited | CO-Check SARS-CoV-2 Antigen LFIA Test (5311-01) | Sanwa BioTech Limited | Package 1
Package 2 |
| 220223 | Xiamen AmonMed Biotechnology Co., Ltd. | 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 17 September 2024
