List of WHO-EUL certified COVID-19 antigen kits
| S.N. | Kit name | Manufacturer | Technique applied |
| 1 | STANDARD Q COVID-19 Ag Test (Nasal) | SD Biosensor,z | Visual read, ICA |
| 2 | Panbio COVID-19 Ag Rapid (Nasopharyngeal) | Abbott Rapid Diagnostics Jena GmbH | Visual read, ICA |
| 3 | Panbio COVID-19 Ag Rapid (Nasal) | Abbott Rapid Diagnostics Jena GmbH | Visual read, ICA |
| 4 | Sure Status COVID-19 Antigen Card Test | Premier Medical Corporation Private Limited | Visual read, ICA |
| 5 | COVID-19 Ag Rapid Test | CTK Biotech, Inc | Visual read, ICA |
List of US-FDA-EUA certified COVID-19 antigen kits
| S.N. | Kit name | Manufacturer | Technique Applied |
| 1 | BinaxNOW COVID-19 Ag Card | Abbott Diagnostics Scarborough, Inc. | Lateral Flow, Visual Read, Single Target |
| 2 | BinaxNOW COVID-19 Ag Card Home Test | Abbott Diagnostics Scarborough, Inc. | Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Telehealth Proctor Supervised, Single Target |
| 3 | BinaxNOW COVID-19 Ag 2 Card | Abbott Diagnostics Scarborough, Inc. | Lateral Flow, Visual Read, Non-prescription Testing, Serial Screening, Single Target |
| 4 | BinaxNOW COVID-19 Antigen Self Test | Abbott Diagnostics Scarborough, Inc. | Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening Single Target |
| 5 | BinaxNOW COVID-19 Ag Card 2 Home Test | Abbott Diagnostics Scarborough, Inc. | Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Telehealth Proctor Supervised, Serial Screening, Single Target |
| 6 | CareStart COVID-19 Antigen Home Test | Access Bio, Inc. | Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target |
| 7 | CareStart COVID-19 Antigen test | Access Bio, Inc. | Lateral Flow, Visual Read, Serial Screening, Single Target |
| 8 | Flowflex COVID-19 Antigen Home Test | ACON Laboratories, Inc | Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Screening, Single Target |
| 9 | NIDS COVID-19 Rapid Test Kit | ANP Technologies, Inc | lateral Flow, Visual Read, Serial Screening, Single Target |
| 10 | BD Veritor System for Rapid Detection of SARS-CoV-2 | Becton, Dickinson and Company (BD) | Chromatographic Digital Immunoassay, Instrument Read, Serial Screening, Single Target |
| 11 | BD Veritor At-Home COVID-19 Test | Becton, Dickinson and Company (BD) | Lateral Flow, Digital Read, Over the Counter (OTC) Home Testing, Serial Screening Single Target |
| 12 | BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B | Becton, Dickinson and Company (BD) | Chromatographic Digital Immunoassay, Instrument Read, Multi-analyte, Single Target |
| 13 | Celltrion DiaTrust COVID-19 Ag Home Test | Celltrion USA, Inc. | Lateral Flow, Visual Read, Over the COunter (OTC) Home Testing, Serial Screening, Multiple Targets |
| 14 | Celltrion DiaTrust COVID-19 Ag Rapid Test | Celltrion USA, Inc. | Lateral Flow, Visual Read, Serial Screening, Multiple Targets |
| 15 | Sampinute COVID-19 Antigen MIA | Celltrion USA, Inc. | Magnetic Force-assisted Electrochemical Sandwich Immunoassay (MESIA), Single Target |
| 16 | LIAISON SARS-CoV-2 Ag | DiaSorin, Inc | CLIA, Single Target |
| 17 | ellume.lab COVID Antigen Test | Ellume LImited | Lateral Flow, Fluorescence, Instrument Read, Single Target |
| 18 | Ellume COVID-19 Home Test | Ellume LImited | Lateral Flow, Fluorescence, Instrument Read, Over the Counter (OTC) Home Testing Screening, Single Target |
| 19 | GenBody COVID-19 Ag | GenBody Inc. | Lateral Flow, Visual Read, Serial Screening Single Target |
| 20 | iHealth COVID-19 Antigen Rapid Test Pro | iHealth Labs, Inc. | Lateral Flow, Visual Read, Serial Screening Single Target |
| 21 | iHealth COVID-19 Antigen Rapid Test | iHealth Labs, Inc. | Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target |
| 22 | sCoV-2 Ag Detect Rapid Self-Test | InBios International Inc. | Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target |
| 23 | sCoV-2 Ag Detect Rapid Test | InBios International Inc. | Lateral Flow, Visual Read, Serial Screening, Single Target |
| 24 | Clip COVID Rapid Antigen Test | Luminostics, Inc | Lateral Flow, immunoluminescent assay, instrument read, Single Target |
| 25 | Lumira Dx SARS-CoV-2 Ag Test | Lumira Dx UK Ltd. | Microfluidic Immunofluorescence Assay, Instrument Read, Screening, Single Target |
| 26 | MaximBio ClearDetect COVID-19 Antigen Home Test | Maxim Biomedical, Inc. | Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening Single Target |
| 27 | Nano-Check COVID-19 Antigen Test | Nano-Ditech Crop | Lateral Flow, Visual Read, Serial Screening, Single Target |
| 28 | InteliSwab COVID-19 Rapid Test Rx | OraSure Technologies, Inc. | Lateral Flow, Visual Read, Prescription Home Testing, Single Target |
| 29 | InteliSwab COVID-19 Rapid Test | OraSure Technologies, Inc. | Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target |
| 30 | InteliSwab COVID-19 Rapid Test Pro | OraSure Technologies, | Chemiluminescence Immunoassay, Instrument Read Single Target |
| 31 | VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack | PHASE Scientific International, Ltd. | Lateral Flow, Visual Read, Serial Screening, Single Target |
| 32 | INDICAID Covid-19 Rapid Antigen Test | Princeton BioMeditech Crop. | Lateral Flow, Visual Read, Multi-analyte, Single Target |
| 33 | Status COVID-19/Flu A&B | QIAGEN GmbH | Digital Lateral Flow, Fluorescence, Instrument Read, Single Target |
| 34 | QIAreach SARS-CoV-2 Antigen | Qorvo Biotechnologies, LLC. | Bulk Asoustic Wave (BAW) Biosensor, Instrument Read, Single Target |
| 35 | Omnia SARS-CoV-2 Antigen Test | Quanterix Corporation | Paramagnetic Microbead-based Immunoassay, Serial Screening, Saliva, Single Target |
| 36 | Simoa SARS-CoV-2 N Protein Antigen Test | Quidel Corporation | Lateral Flow, Visual read, Serial Screening, Single Target |
| 37 | QuickVue SARS Antigen Test | Quidel Corporation | Lateral Flow, Visual read, Over the COunter (OTC) Home Testing, Serial Screeing, Single Target |
| 38 | QuickVue At-Home OTC COVID-19 Test | Quidel Corporation | Lateral flow, Fluorescence, Instrument read, Serial Screening, Single Target |
| 39 | Sofia SARS Antigen FIA | Quidel Corporation | Lateral Flow, Visual Read, Prescription Home Testing, Single Target |
| 40 | QuickVue At-Home COVID-19 Test | Quidel Corporation | Lateral Flow, Flurescence, Instrument Read, Multi-Analyte, Single Target |
| 41 | Sofia 2 Flu+SARS Antigen FIA | Quidel Corporation | Lateral Flow, Visual Read, Single Target |
| 42 | Sienna-Clarity COVID-19 Antigen Rapid Test Cassette | Salofa Oy | Lateral Flow, Visual Read, Single Target |
| 43 | COVID-19 At-Home Test | SD Biosensor, Inc. | Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target |
| 44 | CLINITEST Rapid COVID-19 | Siemens healthineers | Lateral Flow, Visual read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target |
| 45 | SPERA COVID-19 Ag Test | Xtrava Health | Lateral Flow, Visual Read, Single Target |
List of CE-IVD COVID-19 Antigen Test kits with EU HSC Mutual Recognition
| S.No. | Kit Name | Manufature Name |
|---|---|---|
| 1 | COVID-VIRO | AAZ-LMB |
| 2 | Panbio™ COVID-19 Ag Rapid Test | Abbott Rapid Diagnostics |
| 3 | Flowflex SARS-CoV-2 Antigen Rapid Test | Acon Biotech (Hangzhou) Co., Ltd |
| 4 | Flowflex SARS-CoV-2 Antigen Rapid Test | ACON Laboratories, Inc. |
| 5 | AESKU.RAPID SARS-CoV-2 | AESKU.DIAGNOSTICS GmbH & Co, KG |
| 6 | TestNOW® – COVID-19 Antigen Test | Affimedix Inc |
| 7 | AMP Rapid Test SARSCoV-2 Ag | AMEDA Labordiagnostik GmbH |
| 8 | Rapid COVID-19 AntigenTest (colloidal Gold) | Anbio (Xiamen) Biotechnology Co., Ltd |
| 9 | COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold) | Anhui Deep Blue Medical Technology Co., Ltd |
| 10 | COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold) – Nasal swab | Anhui Deep Blue Medical Technology Co., Ltd |
| 11 | mariPOC SARS-CoV-2 | ArcDia International Ltd |
| 12 | mariPOC Respi+ | ArcDia International Oy Ltd |
| 13 | mariPOC Quick Flu+ | ArcDia International Oy Ltd |
| 14 | Artron COVID-19 Antigen Test | Artron Laboratories Inc. |
| 15 | Asan Easy Test COVID-19 Ag | Asan Pharmaceutical Co., Ltd |
| 16 | ECOTEST COVID-19 Antigen Rapid Test Device | Assure Tech. (Hangzhou) Co., Ltd. |
| 17 | ECOTEST COVID-19 Antigen Rapid Test Device | Assure Tech. (Hangzhou) Co., Ltd. |
| 18 | NOVA Test ® SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography) | Atlas Link Technology Co. Ltd. |
| 19 | Ksmart® SARS-COV2 Antigen Rapid Test | Avalun |
| 20 | COVID-19 Antigen Rapid Test | AXIOM Gesellschaft für Diagnostica und Biochemica mbH |
| 21 | COVID-19 Antigen Rapid Test Device | Azure Biotech, Inc. |
| 22 | BD Veritor™ System for Rapid Detection of SARS CoV 2 | Becton Dickinson |
| 23 | Novel Coronavirus 2019- nCoV Antigen Test (Colloidal Gold) | Beijing Hotgen Biotech Co., Ltd |
| 24 | Novel Coronavirus (SARSCoV-2) Antigen Rapid Test Kit | Beijing Jinwofu Bioengineering Technology Co.,Ltd. |
| 25 | SARS-CoV-2 Antigen Rapid Test Kit | Beijing Lepu Medical Technology Co., Ltd |
| 26 | Wantai SARS-CoV-2 Ag Rapid Test (colloidal gold) | Beijing Wantai Biological Pharmacy Enterprise Co., Ltd |
| 27 | CoviGnost AG Test Device 1×20 | BioGnost Ltd |
| 28 | SARS-CoV-2 Antigen Rapid Test Kit (Fluorescence Immunochromato-graphy) | BIOHIT HealthCcare (Hefei) Co., Ltd. |
| 29 | SARS-CoV-2 Ag Rapid Test | BioMaxima SA |
| 30 | Biomerica COVID-19 Antigen Rapid Test (nasopharyngeal swab) | Biomerica Inc. |
| 31 | NowCheck COVID-19 Ag Test | BIONOTE |
| 32 | CORONAVIRUS AG RAPID TEST CASSETTE | BIO-RAD |
| 33 | BIOSYNEX COVID-19 Ag BSS | BIOSYNEX SWISS S.A. |
| 34 | BIOSYNEX COVID-19 Ag+ BSS | BIOSYNEX SA |
| 35 | SARS-CoV-2 Antigen Test Kit (colloidal gold method) | BIOTEKE CORPORATION (WUXI) CO., LTD |
| 36 | biotical SARS-CoV-2 Ag Card | Biotical Health S.L.U.BIOTICAL HEALTH S.L.U |
| 37 | AFIAS COVID-19 Ag | Boditech Med Inc |
| 38 | Rapid Response COVID-19 Antigen Rapid Test | BTNX Inc |
| 39 | CerTest SARS-CoV-2 Card test | CerTest Biotec |
| 40 | CHECK UP SARS-COV-2 NASAL ANTIGEN RAPID TEST | Cesna Biyoteknoloji Araştırma Geliştirme Laboratuvar Sist.İnş.Müh.Dan.San.Tic.Ltd.Şti. |
| 41 | CHECK UP SARS-COV-2 NASOPHARYNGEAL RAPID ANTIGEN TEST | Cesna Biyoteknoloji Araştırma Geliştirme Laboratuvar Sist.İnş.Müh.Dan.San.Tic.Ltd.Şti. |
| 42 | CHIL COVID-19 Antigen Rapid Test (Nasopharyngeal / Oropharyngeal Swab-Casette) | Chil Tıbbi Malzeme Sanayi ve Ticaret Limited Şirketi |
| 43 | 2019-nCoV Antigen Test Kit | Chongqing M&D Biotechnology Co. Ltd |
| 44 | Coretests COVID-19 Ag Test | Core Technology Co., Ltd |
| 45 | OnSite COVID-19 Ag Rapid Test | CTK Biotech, Inc |
| 46 | Test Rapid Covid-19 Antigen (tampon nazofaringian) | DDS DIAGNOSTIC |
| 47 | DIAQUICK COVID -19 Ag Cassette | DIALAB GmbH |
| 48 | COVID-19 Antigen Detection Kit | DNA Diagnostic |
| 49 | SARS-CoV-2 Antigen Rapid Test | DNA Diagnostic |
| 50 | Dräger Antigen Test SARS-CoV-2 | Dräger Safety AG & Co. KGaA |
| 51 | Dynamiker SARS-CoV-2 Ag Rapid Test | Dynamiker Biotechnolgy(Tianjin) Co., Ltd. |
| 52 | Edinburgh Genetics ActivXpress+ COVID-19 Antigen Complete Testing Kit | Edinburgh Genetics Limited |
| 53 | EBS SARS-CoV-2 Ag Rapid Test | Eurobio Scientific |
| 54 | ESPLINE SARS-CoV-2 | Fujirebio |
| 55 | GA CoV-2 Antigen Rapid Test | GA Generic Assays GmbH |
| 56 | Virusee® SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) | Genobio Pharmaceutical Co., Ltd. |
| 57 | SARS-CoV-2 Antigen Test Kit (Colloidal Gold) | Genrui Biotech Inc |
| 58 | GenSure COVID-19 Antigen Rapid Test Kit | GenSure Biotech Inc |
| 59 | SARS-CoV-2 Antigen (Colloidal Gold) | Getein Biotech, Inc |
| 60 | One Step Test for SARS-CoV-2 Antigen (Colloidal Gold) | Getein Biotech, Inc. |
| 61 | Novel Coronavirus (2019-nCoV) Antigen Test Kit (Colloidal gold immunochromatography) | Glallergen CO., LTD. |
| 62 | SARS-CoV-2 Antigen Kit (Colloidal Gold) | Goldsite Diagnostic Inc. |
| 63 | GENEDIA W COVID-19 Ag | Green Cross Medical Science Corp. |
| 64 | 2019-nCoV Antigen Test Kit (colloidal gold method) | Guangdong Hecin Scientific, Inc. |
| 65 | 2019-nCoV Ag Rapid Detection Kit (Immuno-Chromatography) | Guangdong Longsee Biomedical Co., Ltd. |
| 66 | COVID-19 Ag Test Kit | Guangdong Wesail Biotech Co. Ltd |
| 67 | V-CHEK, 2019-nCoV Ag Rapid Test Kit (Immuno-chromatography) | Guangzhou Decheng Biotechnology CO., Ltd |
| 68 | Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) | Guangzhou Wondfo Biotech Co., Ltd |
| 69 | COVID-19 Antigen Rapid Test | Hangzhou AllTest Biotech Co., Ltd |
| 70 | SARS-CoV-2 Antigen Rapid Test (COVID-19 Antigen Rapid Test) (Swab) | Hangzhou Biotest Biotech Co., Ltd |
| 71 | COVID-19 Antigen Rapid Test Casette | Hangzhou Clongene Biotech Co., Ltd. |
| 72 | Covid-19 Antigen Rapid Test Kit | |
| 73 | COVID-19/Influenza A+B Antigen Combo Rapid Test | |
| 74 | Immunobio SARS-CoV-2 Antigen ANTERIOR NASAL Rapid Test Kit (minimal invasive) | Hangzhou Immuno Biotech Co., Ltd |
| 75 | SARS-CoV2 Antigen Rapid Test | Hangzhou Immuno Biotech Co., Ltd |
| 76 | Redtest Professional Sars-CoV-2 Antigen Rapid Test (Covid-19 Ag) | Sigmed Sp. z o.o. |
| 77 | COVID-19 Antigen Test Cassette | Hangzhou DIAN Biotechnology Co., Ltd. |
| 78 | LYHER Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold) | Hangzhou Laihe Biotech Co. |
| 79 | COVID-19 Antigen Rapid Test Device (Colloidal Gold) | Hangzhou Lysun Biotechnology Co. Ltd |
| 80 | SARS-CoV-2 Antigen Rapid Test Cassette | Hangzhou Sejoy Electronics & Instruments Co.Ltd |
| 81 | Covid-19 Antigen Test Cassette | Hangzhou Testsea Biotechnology Co., Ltd. |
| 82 | Coronavirus Ag Rapid Test Cassette | Healgen Scientific |
| 83 | CLINITEST Rapid COVID-19 Antigen Test | Siemens Healthineers |
| 84 | Corona Virus (COVID-19) Antigen Rapid Test (Colloidal Gold) | Hoyotek Biomedical Co.,Ltd. |
| 85 | SARS-CoV-2 Antigen Test Kit | Hubei Jinjian Biology Co., Ltd |
| 86 | Humasis COVID-19 Ag Test | Humasis |
| 87 | Innova SARS-CoV-2 Antigen Rapid Qualitative Test | Innova Medical Group.Inc |
| 88 | Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (Nasal swab) | Innovation Biotech(Beijing) Co.Ltd |
| 89 | Rapid SARS-CoV-2 Antigen Test (nasopharyngeal specimen) | InTec PRODUCTS, INC. |
| 90 | Novel Corona Virus (SARS-CoV-2) Ag Rapid Test Kit | Jiangsu Bioperfectus Technologies Co., Ltd. |
| 91 | COVID-19 Antigen Rapid Test Cassette (Colloidal Gold) | Jiangsu Diagnostics Biotechnology Co., Ltd |
| 92 | SARS-CoV-2 antigen Test Kit (LFIA) | Jiangsu Medomics medical technology Co.,Ltd. |
| 93 | SARS-CoV-2 Antigen Test Cassette | Jiangsu Mole Bioscience CO., LTD. |
| 94 | COVID-19 Ag Rapid Test Device | Jiangsu Well Biotech Co., Ltd. |
| 95 | COVID-19 Rapid Antigen Test (Colloidal Gold) | Joinstar Biomedical Technology Co. Ltd |
| 96 | Covid-19 Antigen Schnelltest (Colloidales Gold) | IEDAU INTERNATIONAL GMBH |
| 97 | SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold immunochromatography) | JOYSBIO (Tianjin) Biotechnology Co., Ltd. |
| 98 | SARS-CoV-2 Antigen Rapid Test Kit | Labnovation Technologies Inc. |
| 99 | COVID-19 Antigen Test Kit (Colloidal Gold) | LINKCARE (NANTONG DIAGNOS BIO) |
| 100 | PocRoc® SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) | Lumigenex (Suzhou) Co., Ltd |
| 101 | QuickProfile™ COVID-19 Antigen Test | LumiQuick Diagnostics Inc. |
| 102 | LumiraDx SARS-CoV-2 Ag Test | LumiraDX |
| 103 | MEDsan SARS-CoV-2 Antigen Rapid Test | MEDsan GmbH |
| 104 | SARS-CoV-2 Antigen Rapid Test Cassette | Merlin Biomedical (Xiamen) Co., Ltd. |
| 105 | MEXACARE COVID-19 Antigen Rapid Test | MEXACARE GmbH |
| 106 | mö-screen Corona Antigen Test | möLab |
| 107 | COVIOS Ag COVID-19 Antigen Rapid Diagnostic Test | Mologic Ltd |
| 108 | Rapid SARS-CoV-2 Antigen Test Card | MP Biomedicals |
| 109 | NADAL COVID -19 Ag +Influenza A/B Test | Nal von minden GmbH |
| 110 | NADAL COVID -19 Ag Test | Nal von minden GmbH |
| 111 | StrongStep® SARS-CoV-2 Antigen Rapid Test | Nanjing Liming Bio-Products Co., Ltd. |
| 112 | Novel Coronavirus (2019-nCoV) Antigen Testing Kit (Colloidal Gold) | Nanjing Norman Biological Technology Co., Ltd. |
| 113 | SARS-COV-2 Nucleocapsid (N) Antigen Rapid Detection Kit (Colloidal gold method) | Nanjing Synthgene Medical Technology Co., Ltd. |
| 114 | FREND COVID-19 Ag | NanoEntek |
| 115 | NanoRepro SARS-CoV-2 Antigen Rapid Test | NanoRepro AG |
| 116 | MARESKIT COVID-19 ANTIGEN RAPID TEST KIT | NESAPOR EUROPA SL |
| 117 | COVID-19 Antigen Detection Kit | New Gene (Hangzhou) Bioengineering Co., Ltd. |
| 118 | Ninonasal | NG Biotech |
| 119 | SARS-CoV-2 Antigen Rapid Test | Novatech |
| 120 | CAT | Oncosem Onkolojik Sistemler San. ve Tic. A.S. |
| 121 | GeneFinder COVID-19 Ag Plus Rapid Test | OSANG Healthcare Co., Ltd. |
| 122 | PCL COVID19 Ag Rapid FIA | PCL Inc. |
| 123 | PCL COVID19 Ag Gold | PCL Inc. |
| 124 | SARS-CoV-2 Antigen Detection Kit (Colloidal Gold Immunochromato-graphic Assay) | PerGrande Bio Tech Development Co., Ltd. |
| 125 | Exdia COVI-19 Ag | Precision Biosensor Inc. |
| 126 | Rapid Test Ag 2019-nCov | Prognosis Biotech |
| 127 | SARS-CoV-2 Antigen Rapid Test (Immunochromatography) | Qingdao Hightop Biotech Co. Ltd |
| 128 | SARS-CoV-2/Flu A+B/RSV Antigen Rapid Test | Qingdao Hightop Biotech Co., Ltd. |
| 129 | Sofia SARS Antigen FIA | Quidel Corporation |
| 130 | LIAISON® Quick Detect Covid Ag Assay | Rapid Pathogen Screening, Inc |
| 131 | SARS-CoV-2 Rapid Antigen Test | Roche (SD BIOSENSOR) |
| 132 | SARS-CoV-2 Rapid Antigen Test Nasal | Roche (SD BIOSENSOR) |
| 133 | COVID-19 Antigen Rapid Test Kit (Swab) | Safecare Biotech (Hangzhou) Co. Ltd |
| 134 | Multi-Respiratory Virus Antigen Test Kit (Swab) (Influenza A+B/COVID-19) | Safecare Biotech (Hangzhou) Co. Ltd |
| 135 | SARS-CoV-2 Rapid Antigen Test (Colloidal Gold Method) | Sansure Biotech Inc |
| 136 | ScheBo SARS CoV-2 Quick Antigen | ScheBo Biotech |
| 137 | ScheBo SARS CoV-2 Quick ANTIGEN (Colloidal Gold Method) | ScheBo Biotech |
| 138 | STANDARD Q COVID-19 Ag Test Nasal | SD Biosensor Inc |
| 139 | STANDARD F COVID-19 Ag FIA | SD BIOSENSOR Inc. |
| 140 | STANDARD Q COVID-19 Ag Test | SD BIOSENSOR Inc. |
| 141 | V-Chek SARS-CoV-2 Ag Rapid Test Kit (Colloidal Gold) | SGA Medikal |
| 142 | V-Chek SARS-CoV-2 Rapid Ag Test (colloidal gold) | SGA Medikal |
| 143 | SARS-CoV-2 Antigen Test Kit | Shenzen Ultra-Diagnostics Biotec Co., Ltd |
| 144 | SARS-CoV-2-Antigen Rapid Detection Kit | Shenzhen CAS-Envision Medical Technology Co., Ltd. |
| 145 | SARS-CoV-2 Antigen Test Kit (Colloidal Gold) | Shenzhen Dymind Biotechnology Co., Ltd |
| 147 | SARS-CoV-2 Antigen Test Kit (GICA) | Shenzhen Kisshealth Biotechnology Co., Ltd |
| 148 | Green Spring SARS-CoV-2 Antigen-Rapid test-Set | Shenzhen Lvshiyuan Biotechnology Co., Ltd. |
| 149 | SARS-CoV-2 Antigen Test Kit (Colloidal Gold Chromatographic Immunoassay) | Shenzhen Microprofit Biotech Co., Ltd |
| 150 | SARS-CoV-2 Spike Protein Test Kit (Colloidal Gold Chromatographic Immunoassay) | Shenzhen Microprofit Biotech Co., Ltd. |
| 151 | SARS-CoV-2 Spike Protein Test Kit (Fluorescence Immunoassay) | Shenzhen Microprofit Biotech Co., Ltd |
| 152 | SARS-CoV-2 antigen IVD kit SWAB | Shenzhen Reagent Technology Co.,Ltd. |
| 153 | SARS-CoV-2 Ag Diagnostic Test Kit (Colloidal Gold) | Shenzhen Watmind Medical Co., Ltd |
| 154 | SARS-CoV-2 Ag Diagnostic Test Kit (Immuno-fluorescence) | Shenzhen Watmind Medical Co., Ltd |
| 155 | GLINE-2019-nCoV Ag | Shenzhen YHLO Biotech Co., Ltd. |
| 156 | Zhenrui ®COVID-19 Antigen Test Cassette | Shenzhen Zhenrui Biotech Co., Ltd |
| 157 | SGTi-flex COVID-19 Ag | Sugentech, Inc. |
| 158 | SARS-CoV-2 Rapid Antigen Test Cassette | SureScreen Diagnostics |
| 159 | COVID-19 Antigen Test Kit | Surge Medical Inc. |
| 160 | TODA CORONADIAG Ag | TODA PHARMA |
| 161 | SARS-CoV-2 Antigen Rapid Test Kit | Triplex International Biosciences(China) Co., Ltd |
| 162 | SARS-CoV-2 Antigen Rapid Test Kit | Triplex International Biosciences Co., Ltd, China |
| 163 | INFO Covid-19 Ag Test | TÜRKLAB TIBBİ MALZEMELER SAN. ve TİC. A.Ş. |
| 164 | Covid-19 Ag Test | TÜRKLAB TIBBİ MALZEMELER SAN. ve TİC. A.Ş. |
| 165 | RAPIDAN TESTER Covid-19 Ag Test | TÜRKLAB TIBBİ MALZEMELER SAN. ve TİC. A.Ş. |
| 166 | TOYO Covid-19 Ag Tes | TÜRKLAB TIBBİ MALZEMELER SAN. ve TİC. A.Ş. |
| 167 | RapidFor SARS-CoV-2 Rapid Ag Test | Vitrosens Biotechnology Co., Ltd |
| 168 | Verino Pro SARS CoV 2 Ag Rapid Test | VivaChek Biotech (Hangzhou) Co., Ltd, China |
| 169 | COVID-19 (SARS-CoV-2) Antigen-Test Kit | Wuhan EasyDiagnosis Biomedicine Co., Ltd. |
| 170 | SARS-CoV-2 Antigen Assay Kit (Immuno-chromatography) | Wuhan Life Origin Biotech Joint Stock Co., Ltd. |
| 171 | SARS-CoV-2 Antigen Rapid Test Kit | Wuhan UNscience Biotechnology Co., Ltd. |
| 172 | SARS-CoV-2 Antigen Test Kit (Lateral Flow Assay) | Wuxi Biohermes Bio & Medical Technology Co., Ltd. |
| 173 | COVID-19 Antigen Rapid Test Kit (Colloidal Gold) | Xiamen AmonMed Biotechnology Co., Ltd |
| 174 | Rapid SARS-CoV-2 Antigen Test Card | Xiamen Boson Biotech Co. Ltd |
| 175 | SARS-CoV-2 Antigen Rapid Test | Xiamen Wiz Biotech Co., Ltd |
| 176 | SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) | Xiamen Wiz Biotech Co., Ltd |
| 177 | AndLucky COVID-19 Antigen Rapid Test | Zhejiang Anji Saianfu Biotech Co.., Ltd |
| 178 | reOpenTest COVID-19 Antigen Rapid Test | Zhejiang Anji Saianfu Biotech Co.., Ltd |
| 179 | Pantest Coronavirus Ag (Nasopharyngeal Swab) | Pantest SA |
| 180 | Novel Coronavirus (COVID-19) Antigen Detection Kit (Swab) | Zhejiang GENE SCIENCE Co., Ltd |
| 181 | Coronavirus Ag Rapid Test Cassette (Swab) | Zhejiang Orient Gene Biotech Co., Ltd |
| 182 | ENCODE SARS-COV-2 Antigen Rapid Test Device | Zhuhai Encode Medical Engineering Co.,Ltd |
| 183 | COVID-19 Antigen Detection Kit (Colloidal Gold) | Zhuhai Lituo Biotechnology Co., Ltd. |
| 184 | LIAISON SARS-CoV-2 Ag assay | DIASORIN |
| 185 | Elecsys® SARS-CoV-2 Antigen | Roche Diagnostics GmbH |
For Reference:
WHO Listed: https://extranet.who.int/pqweb/sites/default/files/documents/210430_EUL_SARS-CoV-2_product_list.pdf
FDA Listed: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2
EU Listed: https://ec.europa.eu/health/sites/default/files/preparedness_response/docs/covid-19_rat_common-list_en.pdf
Notes :
- Subject to change. Revision will be updated in NPHL website.
- This list is subject to change as per reporting and adverse events in post marketing surveillance.