Approved Rapid Antigen tests
Robust testing strategies are an essential part of being prepared and responding to the COVID-19 pandemic. Whilst the polymerase chain reaction (PCR) test remains the ‘gold standard’ for COVID-19 diagnosis, rapid antigen tests/ Lateral Flow tests (LFTs) detect the presence of viral proteins (antigens) and help increase our testing capacity; with a markedly swifter turnaround time for results and no need to be conducted in a clinical setting.
A list of COVID-19 rapid antigen tests that are approved for use in Gibraltar, are provided below:
| Manufacturer | Commercial Name | Date accepted to EU common list |
|---|---|---|
| AAZ-LMB | COVID-VIRO® | 10 May 2021 |
| Abbott Rapid Diagnostics | Panbio™ COVID-19 Ag Rapid Test | 17 February 2021 |
| ABIOTEQ | Cora Gentest-19 | 20 October 2021 |
| AccuBioTech Co.,Ltd | Accu-Tell SARS-CoV-2 Ag Cassette | 20 October 2021 |
| Acon Biotech (Hangzhou) Co., Ltd | Flowflex SARS-CoV-2 Antigen Rapid Test | 14 July 2021 |
| Acon Biotech (Hangzhou) Co., Ltd | Flowflex SARS-CoV-2 Antigen Rapid Test (Nasal / Saliva) | 10 February 2022 |
| Affimedix Inc | TestNOW® – COVID-19 Antigen Test | 10 May 2021 |
| AMEDA Labordiagnostik GmbH | AMP Rapid Test SARS-CoV-2 Ag | 17 February 2021 |
| Anbio (Xiamen) Biotechnology Co., Ltd | Rapid COVID-19 Antigen-Test (colloidal Gold) | 10 May 2021 |
| Anhui Deep Blue Medical Technology Co., Ltd | COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold) | 10 May 2021 |
| Anhui Formaster Biosci Co., Ltd. | New Coronavirus (COVID-19) Antigen Rapid Test | 20 October 2021 |
| ArcDia International Ltd | mariPOC SARS-CoV-2 | 10 May 2021 |
| ArcDia International Oy Ltd | mariPOC Respi+ | 14 July 2021 |
| ArcDia International Oy Ltd | mariPOC Quick Flu+ | 14 July 2021 |
| ARISTA Biotech Pte.LTD. | ARISTA™ COVID-19 Antigen Rapid Test | 8 April 2022 |
| Artron Laboratories Inc. | Artron COVID-19 Antigen Test | 14 July 2021 |
| Asan Pharmaceutical Co., Ltd | Asan Easy Test COVID-19 Ag | 10 May 2021 |
| Assure Tech. (Hangzhou) Co., Ltd. | ECOTEST COVID-19 Antigen Rapid Test Device | 14 July 2021 |
| Avalun | Ksmart® SARS-COV2 Antigen Rapid Test | 7 July 2021 |
| AXIOM Gesellschaft für Diagnostica und Biochemica mbH | COVID-19 Antigen Rapid Test | 10 May 2021 |
| Becton Dickinson | BD Veritor™ System for Rapid Detection of SARS CoV 2 | 7 July 2021 |
| Becton Dickinson | BD Kit for Rapid Detection of SARS-CoV-2 | 10 November 2021 |
| Beijing Hotgen Biotech Co., Ltd | Coronavirus (2019-nCoV)- Antigentest | 21 January 2022 |
| Beijing Hotgen Biotech Co., Ltd | Novel Coronavirus 2019-nCoV Antigen Test (Colloidal Gold) | 10 May 2021 |
| Beijing Jinwofu Bioengineering Technology Co.,Ltd. | Novel Coronavirus (SARS-CoV-2) Antigen Rapid Test Kit | 14 July 2021 |
| Beijing Lepu Medical Technology Co., Ltd | SARS-CoV-2 Antigen Rapid Test Kit | 17 February 2021 |
| Beijing O&D Biotech Co., Ltd. | COVID-19 Antigen Rapid Test | 20 October 2021 |
| Beijing Wantai Biological Pharmacy Enterprise Co., Ltd | Wantai SARS-CoV-2 Ag Rapid Test (colloidal gold) | 14 July 2021 |
| BioGnost Ltd | CoviGnost AG Test Device 1×20 | 23 July 2021 |
| Biohit Healthcare (Hefei) Co., Ltd. | SARS-CoV-2 Antigen Rapid Test (Colloidal Gold Method) | 8 December 2021 |
| Biohit Healthcare (Hefei) Co., Ltd. | SARS-CoV-2 Antigen Rapid Test Kit (Fluorescence Immunochromatography) | 23 July 2021 |
| BIOLAN HEALTH, S.L. | COVID-19 Antigen Rapid Test (Colloidal Gold Method) | 4 March 2022 |
| BioMaxima SA | SARS-CoV-2 Ag Rapid Test | 23 July 2021 |
| Biomerica Inc. | Biomerica COVID-19 Antigen Rapid Test (nasopharyngeal swab) | 7 July 2021 |
| BIONOTE | NowCheck COVID-19 Ag Test | 7 July 2021 |
| BIO-RAD | CORONAVIRUS AG RAPID TEST CASSETTE | 7 July 2021 |
| Bioscience (Tianjin) Diagnostic Technology Co.,Ltd | Novel Coronavirus (2019-nCoV) Antigen Rapid Detection | 10 June 2022 |
| BioSpeedia International | COVID19Speed-Antigen Test BSD_0503 | 21 January 2022 |
| BIOSYNEX SWISS S.A. | BIOSYNEX COVID-19 Ag BSS | 17 February 2022 |
| BIOSYNEX SA | BIOSYNEX COVID-19 Ag+ BSS | 7 July 2021 |
| Boditech Med Inc | AFIAS COVID-19 Ag | 23 July 2021 |
| BIOTEKE CORPORATION (WUXI) CO., LTD | SARS-CoV-2 Antigen Test Kit (colloidal gold method) | 14 July 2021 |
| Biotical Health S.L.U.BIOTICAL HEALTH S.L.U | biotical SARS-CoV-2 Ag Card | 23 July 2021 |
| BTNX Inc | Rapid Response COVID-19 Antigen Rapid Test | 10 May 2021 |
| CerTest Biotec | CerTest SARS-CoV-2 Card test | 17 February 2022 |
| Cesna Biyoteknoloji Araştırma Geliştirme Laboratuvar Sist.İnş.Müh.Dan.San.Tic.Ltd. Şti. | CHECK UP SARS-COV-2 NASAL ANTIGEN RAPID TEST | 21 December 2021 |
| Cesna Biyoteknoloji Araştırma Geliştirme Laboratuvar Sist.İnş.Müh.Dan.San.Tic.Ltd. Şti. | CHECK UP SARS-COV-2 NASOPHARYNGEAL RAPID ANTIGEN TEST | 21 December 2021 |
| Changzhou Biowin Pharmaceutical Co.,Ltd. | Novel Coronavirus(COVID-19) Antigen Test Kit (Colloidal Gold) | 10 June 2022 |
| Chil Tıbbi Malzeme Sanayi ve Ticaret Limited Şirketi | CHIL COVID-19 Antigen Rapid Test (Nasopharyngeal / Oropharyngeal Swab-Casette) | 20 October 2021 |
| Chongqing M&D Biotechnology Co. Ltd | 2019-nCoV Antigen Test Kit | 20 October 2021 |
| Citest Diagnostics Inc. | COVID-19 Antigen Rapid Test (Nasal Swab) | 10 June 2022 |
| CTK Biotech, Inc | OnSite COVID-19 Ag Rapid Test | 7 July 2021 |
| DDS DIAGNOSTIC | Test Rapid Covid-19 Antigen (tampon nazofaringian) | 10 May 2021 |
| DIALAB GmbH | DIAQUICK COVID -19 Ag Cassette | 10 June 2022 |
| DNA Diagnostic | COVID-19 Antigen Detection Kit | 23 July 2021 |
| DNA Diagnostic | SARS-CoV-2 Antigen Rapid Test | 21 January 2022 |
| Dräger Safety AG & Co. KGaA | Dräger Antigen Test SARSCoV-2 | 20 October 2021 |
| Dynamiker Biotechnolgy (Tianjin) Co., Ltd. | Dynamiker SARS-CoV-2 Ag Rapid Test | 20 October 2021 |
| Edinburgh Genetics Limited | Edinburgh Genetics ActivXpress+ COVID-19 Antigen Complete Testing Kit | 14 July 2021 |
| Eurobio Scientific | EBS SARS-CoV-2 Ag Rapid Test | 7 July 2021 |
| Fosun Diagnostics (Shanghai) Co.,Ltd., China | Fosun Covid-19 Ag Card | 4 March 2022 |
| Fujirebio | ESPLINE SARS-CoV-2 | 7 July 2021 |
| GA Generic Assays GmbH | GA CoV-2 Antigen Rapid Test | 23 July 2021 |
| GenBody Inc | GenBody COVID-19 Ag Test | 8 April 2022 |
| Genobio Pharmaceutical Co., Ltd. | Virusee® SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) | 8 December 2021 |
| Genrui Biotech Inc | SARS-CoV-2 Antigen Test Kit (Colloidal Gold) | 7 July 2021 |
| GenSure Biotech Inc | GenSure COVID-19 Antigen Rapid Test Kit | 10 May 2021 |
| Getein Biotech, Inc | One Step Test for SARS-CoV-2 Antigen (Colloidal Gold) | 16 June 2021 |
| Getein Biotech, Inc | SARS-CoV-2 Antigen (Colloidal Gold) | 14 July 2021 |
| Glallergen CO., LTD. | Novel Coronavirus (2019-nCoV) Antigen Test Kit (Colloidal gold immunochromatography) | 21 December 2021 |
| Goldsite Diagnostic Inc | SARS-CoV-2 Antigen Kit (Colloidal Gold) | 14 July 2021 |
| Guangdong Longsee Biomedical Co., Ltd. | 2019-nCoV Ag Rapid Detection Kit (Immuno-Chromatography) | 1 July 2021 |
| Guangdong Wesail Biotech Co. Ltd | COVID-19 Ag Test Kit | 17 February 2021 |
| Guangzhou Decheng Biotechnology CO., Ltd | V-CHEK, 2019-nCoV Ag Rapid Test Kit (Immuno-chromatography) | 7 July 2021 |
| Hangzhou AllTest Biotech Co., Ltd | COVID-19 Antigen Test Cassette (Nasopharyngeal Swab) (FIA) | 8 April 2022 |
| Hangzhou AllTest Biotech Co., Ltd | COVID-19 Antigen Rapid Test | 10 May 2021 |
| Hangzhou AllTest Biotech Co., Ltd | SARS-CoV-2 Antigen Rapid Test (Nasal Swab) | 4 March 2022 |
| Hangzhou AllTest Biotech Co., Ltd | CVAG4080A – GSD NovaGen SARS-CoV-2 Ag Rapid Test (NP Swab) | 10 June 2022 |
| Hangzhou Clongene Biotech Co., Ltd. | COVID-19 Antigen Rapid Test Casette Covid-19 Antigen Rapid Test Kit COVID-19/Influenza A+B Antigen Combo Rapid Test | 7 July 2021 17 February 2021 10 May 2021 |
| Hangzhou DIAN Biotechnology Co., Ltd. | COVID-19 Antigen Test Cassette | 21 December 2021 |
| Hangzhou Funworld Biotech Co., Ltd | SARS-CoV-2 Antigen Rapid Test Device | 8 April 2022 |
| Hangzhou GENESIS Biodetection and Biocontrol CO.,LTD | KaiBiLi COVID-19 Antigen Pro | 10 June 2022 |
| Hangzhou Jucheng Medical Products Co., Ltd | SARS-CoV-2 Ag Rapid Test Kit | 8 April 2022 |
| Hangzhou Laihe Biotech Co. | LYHER Novel Coronavirus (COVID19) Antigen Test Kit (Colloidal Gold) | 10 May 2022 |
| Hangzhou Lysun Biotechnology Co. Ltd | COVID-19 Antigen Rapid Test Device (Colloidal Gold) | 10 May 2022 |
| Hangzhou Sejoy Electronics & Instruments Co.Ltd | SARS-CoV-2 Antigen Rapid Test Cassette | 8 December 2021 |
| Hangzhou Sejoy Electronics & Instruments Co.Ltd | SARS-CoV-2 Antigen Rapid Test Cassette | 10 June 2022 |
| Hangzhou Testsea Biotechnology Co., Ltd. | SARS-CoV-2 Antigen Rapid Test Cassette (nasal, nasopharyngeal, oropharyngeal, saliva) | 10 May 2022 |
| Hangzhou Zheda Dixun Biological Gene Engineering Co., Ltd. | Covid-19 Antigen Test Cassette | 6 May 2021 |
| Healgen Scientific | Coronavirus Ag Rapid Test Cassette | 17 February 2021 |
| Hoyotek Biomedical Co., Ltd. | Corona Virus (COVID-19) Antigen Rapid Test (Colloidal Gold) | 20 October 2021 |
| Hubei Jinjian Biology Co., Ltd | SARS-CoV-2 Antigen Test Kit | 23 July 2021 |
| Immunospark s.r.l. | Rapid SARS-Cov2 Antigen Test | 6 May 2022 |
| Innova Medical Group.Inc | Innova SARS-CoV-2 Antigen Rapid Qualitative Test | 20 October 2021 |
| Innovation Biotech(Beijing) Co.Ltd | Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (Nasal swab) | 20 October 2021 |
| InTec PRODUCTS, INC | Rapid SARS-CoV-2 Antigen Test (nasopharyngeal specimen) | 20 October 2021 |
| InTec PRODUCTS, INC | Rapid SARS-CoV-2 Antigen Test (nasopharyngeal/nasal specimen) | 8 October 2021 |
| Inzek International Trading B.V. | Biozek covid-19 Antigen Rapidtest BCOV-502 | 4 March 2022 |
| Jiangsu Bioperfectus Technologies Co., Ltd. | Novel Corona Virus (SARS-CoV-2) Ag Rapid Test Kit | 14 July 2021 |
| Jiangsu Diagnostics Biotechnology Co., Ltd | COVID-19 Antigen Rapid Test Cassette (Colloidal Gold) | 14 July 2021 |
| Jiangsu Konsung Bio-Medical Science and Technology Co | COVID-19 Antigen Rapid Test Kit (Colloidal Gold) | 10 February 2022 |
| Jiangsu Medomics medical technology Co.,Ltd. | SARS-CoV-2 antigen Test Kit (LFIA) | 7 July 2021 |
| Jiangsu Mole Bioscience CO., LTD. | SARS-CoV-2 Antigen Test Cassette | 8 December 2021 |
| Jiangsu Well Biotech Co., Ltd. | COVID-19 Ag Rapid Test Device | 20 October 2021 |
| Jiangxi Province JinHuan Medical Instrument Co., LTD. | DREHA Novel Coronavirus (SARSCoV-2) Antigen Rapid Detection Kit | 8 April 2022 |
| JINAN BABIO BIOTECHNOLOGY CO., LTD., China | SARS-CoV-2 Antigen Rapid Detection Kit (Colloidal Gold Method) | 10 February 2022 |
| Joinstar Biomedical Technology Co. Ltd IEDAU INTERNATIONAL GMBH | COVID-19 Rapid Antigen Test (Colloidal Gold) Covid-19 Antigen Schnelltest (Colloidales Gold) | 17 February 2021 8 December 2021 |
| JOYSBIO (Tianjin) Biotechnology Co., Ltd. | SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) | 10 May 2022 |
| Labnovation Technologies Inc | SARS-CoV-2 Antigen Rapid Test Kit | 10 May 2021 |
| Lifecosm Biotech Limited | COVID-19 Antigen Test Cassette | 6 May 2022 |
| LINKCARE (NANTONG DIAGNOS BIO) | COVID-19 Antigen Test Kit (Colloidal Gold) | 21 December 2021 |
| Lumigenex (Suzhou) Co., Ltd | PocRoc® SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) | 10 May 2021 |
| LumiQuick Diagnostics Inc | QuickProfile™ COVID-19 Antigen Test | 10 May 2021 |
| LumiraDX | LumiraDx SARS-CoV-2 Ag Test | 17 February 2021 |
| MEDsan GmbH | MEDsan SARS-CoV-2 Antigen Rapid Test | 17 February 2021 |
| Merlin Biomedical (Xiamen) Co., Ltd. | SARS-CoV-2 Antigen Rapid Test Cassette | 16 June 2021 |
| MEXACARE GmbH | MEXACARE COVID-19 Antigen Rapid Test | 7 July 2021 |
| möLab | mö-screen Corona Antigen Test | 10 May 2021 |
| Mologic Ltd | COVIOS Ag COVID-19 Antigen Rapid Diagnostic Test | 8 December 2021 |
| MP Biomedicals | Rapid SARS-CoV-2 Antigen Test Card | 17 February 2021 |
| Multi-G bvba | Covid19Check-NAS | 10 February 2022 |
| Nanjing Liming Bio-Products Co., Ltd. | StrongStep® SARS-CoV-2 Antigen Rapid Test | 8 December 2021 |
| Nanjing Norman Biological Technology Co., Ltd. | Novel Coronavirus (2019-nCoV) Antigen Testing Kit (Colloidal Gold) | 10 November 2021 |
| Nanjing Synthgene Medical Technology Co., Ltd. | SARS-COV-2 Nucleocapsid (N) Antigen Rapid Detection Kit (Colloidal gold method) | 21 January 2022 |
| NanoRepro AG | NanoRepro SARS-CoV-2 Antigen Rapid Test | 14 July 2021 |
| Nantong Egens Biotechnology Co.,Ltd | COVID-19 Antigen Rapid Test Kit | 10 February 2022 |
| Neo-nostics (Suzhou) Bioengineering Co., Ltd. | COVID 19 Antigen Test Kit (Colloidal Gold Method) | 10 February 2022 |
| NESAPOR EUROPA SL | MARESKIT COVID-19 ANTIGEN RAPID TEST KIT | 23 July 2021 |
| New Gene (Hangzhou) Bioengineering Co., Ltd. | COVID-19 Antigen Detection Kit | 16 June 2021 |
| NG Biotech | Ninonasal | 10 November 2021 |
| OSANG Healthcare Co., Ltd. | GeneFinder COVID-19 Ag Plus Rapid Test | 21 December 2021 |
| Novatech Tıbbi Cihaz Ürünleri Sanayi ve Ticaret A.Ş. | SARS-CoV-2 Antigen Rapid Test | 14 July 2021 |
| Oncosem Onkolojik Sistemler San. ve Tic. A.S. | CAT | 10 May 2021 |
| PCL Inc. | PCL COVID19 Ag Rapid FIA | 10 May 2021 |
| PCL Inc. | PCL COVID19 Ag Gold | 7 July 2021 |
| PerGrande Bio Tech Development Co., Ltd. | SARS-CoV-2 Antigen Detection Kit (Colloidal Gold Immunochromatographic Assay) | 10 May 2021 |
| Pierenkemper GmbH | (SARS-CoV-2) Antigen Rapid Test COVIDENT (SWAB) COVID-19 | 4 March 2022 |
| Precision Biosensor Inc | Exdia COVI-19 Ag | 17 February 2021 |
| PRIMA Lab SA | COVID-19 Antigen Rapid Test | 8 April 2022 |
| Prognosis Biotech | Rapid Test Ag 2019-nCov | 7 July 2021 |
| Qingdao Hightop Biotech Co., Ltd | SARS-CoV-2 Antigen Rapid Test | 17 February 2021 |
| Qingdao Hightop Biotech Co., Ltd | SARS-CoV-2/Flu A+B/RSV Antigen Rapid Test | 21 December 2021 |
| Quidel Corporation | Sofia SARS Antigen FIA | 17 February 2021 |
| Rapid Pathogen Screening, Inc | LIAISON® Quick Detect Covid Ag Assay | 23 July 2021 |
| Roche (SD BIOSENSOR) | SARS-CoV-2 Rapid Antigen Test | 10 May 2021 |
| Roche (SD BIOSENSOR) | SARS-CoV-2 Rapid Antigen Test Nasal | 7 July 2021 |
| Safecare Biotech (Hangzhou) Co. Ltd | COVID-19 Antigen Rapid Test Kit (Swab) Multi-Respiratory Virus Antigen Test Kit (Swab) (Influenza A+B/COVID-19) | 17 February 2021 10 May 2021 |
| Sansure Biotech Inc | SARS-CoV-2 Rapid Antigen Test (Colloidal Gold Method) | 21 December 2021 |
| ScheBo Biotech | ScheBo SARS CoV-2 Quick Antigen | 16 June 2021 |
| ScheBo Biotech | ScheBo SARS CoV-2 Quick ANTIGEN (Colloidal Gold Method) | 21 January 2022 |
| SD Biosensor Inc. | STANDARD Q COVID-19 Ag Test Nasal | 7 July 2021 |
| SD Biosensor Inc. | STANDARD F COVID-19 Ag FIA | 17 February 2021 |
| SD Biosensor Inc. | STANDARD F COVID-19 Ag Test | 17 February 2021 |
| SGA Medikal | V-Chek SARS-CoV-2 Ag Rapid Test Kit (Colloidal Gold) V-Chek SARS-CoV-2 Rapid Ag Test (Colloidal gold) | 10 May 2021 7 July 2021 |
| Shenzhen CAS-Envision Medical Technology Co., Ltd. | SARS-CoV-2-Antigen Rapid Detection Kit | 8 December 2021 |
| Shenzhen Dymind Biotechnology Co., Ltd | SARS-CoV-2 Antigen Test Kit (Colloidal Gold) | 20 October 2021 |
| Shenzhen Huaree Technology Co.,Ltd | SARS-CoV-2 Antigen Rapid Test Kit (Immunochromatography) | 6 May 2022 |
| Shenzhen Huian Biosci Technology Co., Ltd. | SARS-CoV-2 Antigen Test Kit (Colloidal Gold) | 20 October 2021 |
| Shenzhen Kingfocus Biomedical Engineering Co., Ltd. | COVID-19 Antigen Detection Kit (Quantum Dots-Based Immunofluorescence Chromatography) | 8 April 2022 |
| Shenzhen Kisshealth Biotechnology Co., Ltd | SARS-CoV-2 Antigen Test Kit (GICA) | 20 October 2021 |
| Shenzhen Lvshiyuan Biotechnology Co., Ltd. | Green Spring SARS-CoV-2 AntigenRapid test-Set | 10 May 2021 |
| Shenzhen Microprofit Biotech Co., Ltd | SARS-CoV-2 Antigen Test Kit (Colloidal Gold Chromatographic Immunoassay) | 7 July 2021 |
| Shenzhen Microprofit Biotech Co., Ltd | SARS-CoV-2 Spike Protein Test Kit (Colloidal Gold Chromatographic Immunoassay) | 23 July 2021 |
| Shenzhen Microprofit Biotech Co., Ltd. | SARS-CoV-2 Spike Protein Test Kit (Fluorescence Immunoassay) | 8 December 2021 |
| Shenzhen Reagent Technology Co.,Ltd. | SARS-CoV-2 antigen IVD kit SWAB | 20 October 2021 |
| Shenzhen Ultra-Diagnostics Biotec Co., Ltd | SARS-CoV-2 Antigen Test Kit | 10 May 2021 |
| Shenzhen Watmind Medical Co., Ltd | SARS-CoV-2 Ag Diagnostic Test Kit (Colloidal Gold) | 10 May 2021 |
| Shenzhen Watmind Medical Co., Ltd | SARS-CoV-2 Ag Diagnostic Test Kit (Immuno-fluorescence) | 7 July 2021 |
| Shenzhen YHLO Biotech Co., Ltd. | GLINE-2019-nCoV Ag | 8 December 2021 |
| Siemens Healthineers | CLINITEST Rapid COVID-19 Antigen Test | 17 February 2021 |
| Spring Healthcare Services AG | SARS-Cov-2 Antigen Rapid Test Cassette (swab) | 10 June 2022 |
| Sugentech, Inc. | SGTi-flex COVID-19 Ag | 10 May 2021 |
| SureScreen Diagnostics | SARS-CoV-2 Rapid Antigen Test Cassette | 20 October 2021 |
| Surge Medical Inc. | COVID-19 Antigen Test Kit | 21 January 2022 |
| Suzhou Soochow University Saier Immuno Biotech Co., Ltd. | InstantSure Covid-19 Ag CARD | 20 October 2021 |
| TBG BIOTECHNOLOGY XIAMEN INC. | SARS-CoV-2 Antigen Rapid Test (Nasal Swab) | 10 June 2022 |
| TODA PHARMA | TODA CORONADIAG Ag | 10 May 2021 |
| Triplex International Biosciences(China) CO.,LTD. | SARS-CoV-2 Antigen Rapid Test Kit | 16 June 2021 |
| Triplex International Biosciences(China) CO.,LTD | SARS-CoV-2 Antigen Rapid Test Kit | 14 July 2021 |
| TÜRKLAB TIBBİ MALZEMELER SAN. ve TİC. A.Ş. | Covid-19 Ag Test INFO Covid-19 Ag Test RAPIDAN TESTER Covid-19 Ag Test TOYO Covid-19 Ag Test | 21 January 2022 21 December 2021 21 December 2021 21 January 2022 |
| Vitrosens Biotechnology Co., Ltd | RapidFor SARS-CoV-2 Rapid Ag Test | 10 May 2021 |
| VivaChek Biotech (Hangzhou) Co. Ltd | SARS-CoV-2 Rapid Test | 10 June 2022 |
| Willi Fox GmbH | Willi Fox COVID-19 Antigen rapid test | 10 June 2022 |
| Wuhan EasyDiagnosis Biomedicine Co., Ltd. | COVID-19 (SARS-CoV-2) AntigenTest Kit | 10 May 2021 |
| Wuhan HealthCare Biotechnology Co. Ltd. | SARS-CoV-2 Antigen Test Kit (Colloidal Gold) | 4 March 2022 |
| Wuhan Life Origin Biotech Joint Stock Co., Ltd. | SARS-CoV-2 Antigen Assay Kit (Immuno-chromatography) | 14 July 2021 |
| Wuhan UNscience Biotechnology Co., Ltd. | SARS-CoV-2 Antigen Rapid Test Kit | 7 July 2021 |
| Wuxi Biohermes Bio & Medical Technology Co., Ltd. | SARS-CoV-2 Antigen Test Kit (Lateral Flow Assay) | 20 October 2021 |
| Xiamen AmonMed Biotechnology Co., Ltd | COVID-19 Antigen Rapid Test Kit (Colloidal Gold) | 10 May 2021 |
| Xiamen Boson Biotech Co. Ltd | Rapid SARS-CoV-2 Antigen Test Card | 17 February 2021 |
| Zhejiang Anji Saianfu Biotech Co.., Ltd Pantest SA | AndLucky COVID-19 Antigen Rapid Test reOpenTest COVID-19 Antigen Rapid Test Pantest Coronavirus Ag (Nasopharyngeal Swab) | 10 May 2021 10 May 2021 8 December 2021 |
| Zhejiang GENE SCIENCE Co., Ltd | Novel Coronavirus (COVID-19) Antigen Detection Kit (Swab) | 8 December 2021 |
| Zhejiang Orient Gene Biotech Co., Ltd | Coronavirus Ag Rapid Test Cassette (Swab) | 17 February 2021 |
| Zhuhai Encode Medical Engineering Co.,Ltd | ENCODE SARS-COV-2 Antigen Rapid Test Device | 20 October 2021 |
| Zhuhai Lituo Biotechnology Co., Ltd. (manufacturer) | COVID-19 Antigen Detection Kit (Colloidal Gold) | 14 July 2021 |
| Zybio Inc. | SARS-CoV-2 Antigen Assay Kit (Colloidal Gold Method) | 4 March 2022 |