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 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: 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

Listed Rapid Antigen Tests for COVID-19
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
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
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 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

Listed Rapid Antigen Tests for COVID-19
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
230253 Phase Scientific International Limited 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 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
220016 SD Biosensor, Inc. Roche, SARS-CoV-2 Antigen Self Test Nasal (9901-NCOV-06G) Roche Diagnostics (Hong Kong) Limited Package
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

Listed Rapid Antigen Tests for COVID-19
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
220015 SD Biosensor, Inc. Roche, SARS-CoV-2 Rapid Antigen Test Nasal (9901-NCOV-03G) Roche Diagnostics (Hong Kong) Limited Package
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.

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


Last update on 28 March 2024