PRODUCT EVALUATION STATUS ANTIGEN TEST KITS

Updated as of September 29, 2021

NoProduct NameManufacturerSTATUS
1Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method)Guanzhou Wondfo Biotech Co., Ltd.STAGE 2
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2SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold)Joysbio(Tianjin) Biotechnology Co., Ltd.STAGE 2
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3Standard™ F COVID-19 Ag FIASd Biosensor Inc.STAGE 2
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4Panbio COVID-19 Ag Rapid Test Device (NASAL)Abbot Rapid Diagnostics Jena GmbhSTAGE 2
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5PanbioTM COVID-19 Ag Rapid Test Device (NASAL)Abbott Diagnostics Korea Inc.STAGE 2
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6Standard Q COVID-19 Ag Test (Nasal swab)SD Biosensor, Inc.STAGE 2
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7Sure Status Covid-19 Antigen Card testPremier Medical Corporation Private LimitedSTAGE 2
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8AFIAS COVID-19 AgBoditech Med Inc.STAGE 3
Ongoing evaluation
9VivaDiagTM SARS-CoV-2 Ag Rapid TestVivachek Biotech Hangzhou Co. Ltd.STAGE 3
Ongoing evaluation
10SAVANT™ New Coronavirus (SARS-CoV-2) N Protein Detection Kit (Fluorescence Immunochromatography)Beijing Savant Biotechnology Co. LtdSTAGE 3
Ongoing evaluation
11COVID-19 Antigen Rapid Test (Latex)Joinstar Biomedical Technology Co., LtdSTAGE 3
Ongoing evaluation
12(2019-nCov) New Coronavirus Antigen Test (Colloidal GoldNantong Diagnos Biotechnology Co LtdSTAGE 3
Ongoing evaluation
13SGTi-flex COVID-19 AgSugentech Inc.STAGE 3
Ongoing evaluation
14Camtech COVID-19 Antigen Rapid TestCamtech Biomedical Pte. LtdSTAGE 3
Ongoing evaluation
15SARS-CoV-2 Rapid Antigen TestSD Biosensor Inc. (Roche)STAGE 2
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16SARS-CoV-2 (COVID-19) Antigen Rapid Detection KitTsinglight (Wuhan) Biotechnology Co., Ltd.STAGE 2
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17Sofia 2 Flu + SARS Antigen FIAQuidel CorporationSTAGE 2
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18Helix i-SARS-CoV-2 Ag Rapid Test (Lateral Flow Chromatographic Immunoassay)Helix, Inc.STAGE 2
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19CareStart COVID-19 Antigen testAccess Bio, Inc.STAGE 2
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20PARTNERS COVID-19 Antigen Rapid Test CassetteHangzhou Biotest Biotech Co., Ltd.STAGE 2
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21GENEDIA W COVID-19 AGGreen Cross Medical ScienceSTAGE 2
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22COVID-19 and Influenza A+B Antigen Combo Rapid TestHangzhou Alltest Biotech Co., Ltd.STAGE 2
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23SARS-CoV-2 Antigen Test Kit (Colloidal Gold)Genrui Biotech Inc.STAGE 2
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24Novel coronavirus (2019-nCoV) antigen detection kit (latex method)Beijing Jinwofu Bioengineering Technology Co., Ltd.STAGE 2
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25VivaDiag SARS-CoV-2 Ag FIA Test VID44Vivachek Biotech Hangzhou Co. Ltd.STAGE 2
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26InnoScreen COVID-19 Antigen Rapid Test DeviceInnovation Scientific Pty LtdSTAGE 2
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27VSTRIP COVID-19 Antigen Rapid TestPanion & Bf Biotech Inc.STAGE 2
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28Dynamiker SARS-CoV-2 Ag Rapid TestDynamiker Biotechnology (Tianjin) Co., Ltd.STAGE 2
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29COVID-19 Antigen Rapid Test (Colloidal Gold)Joinstar Biomedical Technology Co., LtdSTAGE 2
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30VTRUST COVID-19 (SARS-COV-2) Antigen Rapid TestTaidoc Technology Corporation Wugu FactorySTAGE 2
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31COVID-19 Antigen TestArtron Laboratories Inc.STAGE 2
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322019-nCoV Ag Test (Latex Chromatography Assay)Innovita (Tangshan) Biological Technology Co., Ltd.STAGE 2
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33FORA COVID-19 Antigen Rapid TestTaidoc Technology Corporation Wugu FactorySTAGE 2
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34Humasis COVID-19 Ag TestHumasis Co., Ltd.STAGE 2
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35OnSite® COVID-19 Ag Point of care testCTK Biotech Inc.STAGE 2
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36VivaDiag™ PRO SARS-CoV-2 Ag Rapid TestVivachek Biotech Hangzhou Co. Ltd.STAGE 2
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37VITROS Immunodiagnostic Products SARSCoV- 2 Antigen Reagent Pack (619 9941)Ortho-Clinical Diagnostics, Inc.STAGE 2
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38Elecsys SARS-CoV-2 Antigen Test E1GRoche Diagnostic GmbhSTAGE 2
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39SURGITECH COVID-19 Ag Rapid TestCTK Biotech Inc.STAGE 2
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40Aria COVID-19 Ag Rapid Test (Nasopharyngeal Swab)CTK Biotech Inc.STAGE 2
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41Cellex qSARS-CoV-2 Antigen Rapid Test (Lateral Flow Chromatographic Immunoassay)Cellex Inc.STAGE 2
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42MAGLUMI SARS-CoV-2 Ag (CLIA)Shenzhen New Industries Biomedical Engineering Co., Ltd.STAGE 2
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43SARS-COV-2 ANTIGEN ASSAY KIT (COLLOIDAL GOLD METHOD)Zybio, Inc.STAGE 2
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44SARS-CoV-2 AntigenDia.Pro Diagnostic Bioprobes S.r.lSTAGE 2
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45Elecsys SARS-CoV-2 Antigen Test (Catalog No. 09345299190)Roche Diagnostics GmbH,STAGE 2
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46COVID-19 SALIVARY ANTIGEN RAPID TEST KIT (COLLOIDAL GOLD)Jiangsu Konsung Bio-Medical Science and Technology Co., LtdSTAGE 2
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47V-CODE ENCODE SARS-COV-2 Antigen Rapid Test DeviceZhuhai Encode Medical Engineering Co., LtdSTAGE 2
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48COVID-19 Antigen Test Kit (Dry Fluorescence Immunoassay)ARTRON LABORATORIES INC.STAGE 2
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49HANGZHOU ALLTEST COVID-19 ANTIGEN RAPID TESTHangzhou AllTest Biotech Co., LtdSTAGE 2
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50CHORUS SARS-CoV-2 Antigen Code: 81410DIESSE Diagnostica Senese S.p.ASTAGE 2
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51Asan Easy Test® COVID-19 Ag (Specimen: Nasopharyngeal Swab)Asan Pharmaceutical Co., Ltd.STAGE 2
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52Dynamiker SARS-CoV-2 Ag Rapid Test (Specimen: Saliva)Dynamiker Biotechnology (Tianjin) Co., Ltd.STAGE 2
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53SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) SPECIMEN- ORAL FLUIDS: SALIVAJOYSBIO(Tianjin) Biotechnology Co., Ltd.STAGE 2
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54ORIGHT COVID-19 Antigen Rapid Test CassetteHangzhou Biotest Biotech Co., Ltd.STAGE 2
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55HEALGEN® Coronavirus Ag Rapid Test Cassette (Swab)Healgen Scientific Limited Liability CompanySTAGE 2
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56CLUNGENE® COVID-19 Antigen Rapid Test CassetteHangzhou Clongene Biotech Co. LtdSTAGE 2
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57NanoCare™ COVID-19 Antigen (Ag) KitNanoBiolife, IncSTAGE 2
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58SARS-CoV-2 & Influenza A/B Antigen Combo Rapid Test Kit (Medomics)Firstep Bioresearch, Inc.STAGE 2
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59SARS-CoV-2 & Influenza A/B Antigen Combo Rapid Test Kit (Medomics)Jiangsu Medomics medical technology Co., LtdSTAGE 2
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60VAZYME Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antigen Detection Kit (Colloidal Gold-Based)Nanjing Vazyme Medical Technology Co. LtdSTAGE 2
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61AllCheck COVID 19 AgCALTH lNCSTAGE 2
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62FUJIFILM COVID-19 Ag TestFUJIFILM CORPORATIONSTAGE 2
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63Hangzhou Alltest COVID-19 Antigen Rapid Test (Nasopharyngeal Swab)Hangzhou AllTest Biotech Co., LtdSTAGE 2
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64COVID-19 Antigen Rapid Test Cassette (Saliva)Hangzhou Biotest Biotech Co., Ltd.STAGE 2
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65Novel Coronavirus(2019-nCoV) Antigen Rapid TestBioscience (Tianjin) Diagnostic Technology Co.,LtdSTAGE 2
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66COVID-19 Antigen Rapid Test (Oral Fluid)Hangzhou AllTest Biotech Co., Ltd.STAGE 2
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67Rapid Response® COVID-19 Antigen Rapid Test DeviceBTNX INC.STAGE 2
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68CLEAREPI™ SARS-CoV-2 COVID Detect Antigen Rapid TestBiolidics LtdSTAGE 2
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69SARS CoV-2 Antigen Rapid Test Kit (Saliva Test)Ningbo Home Test Bio-technology Co.,Ltd.STAGE 2
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70CareUs Covid-19 AntigenWELLS BIO, INC.STAGE 2
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71QuickVue SARS Antigen TestQuidel Corporation- 10165 McKellar Court, San Diego, CA 92121 USASTAGE 2
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72ImmTek™ COVID 19 Antigen Rapid TestMetas Biomedical IncSTAGE 2
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73Monocent SARS-COV-2 Antigen Rapid TestMonocent, Inc.STAGE 2
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74Veri-Q Covid-19 Ag Rapid TestMiCo Biomed Co. Ltd.STAGE 2
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75PCL COVID19 Ag GoldPCL, Inc.STAGE 2
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76Clinitest Rapid COVID19 Antigen TestHealgen Scientific Limited Liability CompanySTAGE 2
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77Alltest COVID-19 Antigen Rapid Test (Oral
Fluid)
Hangzhou Alltest Biotech Co., Ltd.STAGE 2
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782019-nCoV Ag Test (Latex Chromatography Assay)Innovita (Tangshan) Biological Technology Co., LtdSTAGE 2
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792019- nCoV Antigen Rapid TestUstar Biotechnologies ( Hangzhou) LtdSTAGE 2
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80GLINE-2019-nCoV Ag SalivaSHENZHEN YHLO BIOTECH CO., LTDSTAGE 2
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81SARS-CoV-2 Antigen Rapid Test Kit - Saliva (Colloidal Gold)JOYSBIO (Tianjin) Biotechnology Co., LtdSTAGE 2
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82NADAL COVID-19 Ag Test
nal von minden GmbHSTAGE 2
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83Covid-19 Antigen Test KitArtron Laboratories Inc.STAGE 2
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84COVID-19 Antigen Test CassetteHangZhou Testsea biotechnology Co., LtdSTAGE 2
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85SARS-CoV-2 ANTIGEN TEST KIT (COLLOIDAL GOLD METHOD)BIOTEKE CORPORATION (Wuxl) CO., LTD.STAGE 2
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86SARS-COV-2 Nucleocapsid (N) Antigen Rapid
Detection Kit (Colloidal gold method)
Synthgene Medical Technology Co., Ltd.STAGE 2
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87COVID-19 ANTIGEN RAPID DIAGNOSTIC TESTMOLOGIC LTD.STAGE 2
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88AllCheck COVID-19 Ag Test Kit (One Step COVID-19
Antigen Test)
CALTH Inc.STAGE 2
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89Vazyme Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antigen Detection Kit (Colloidal Gold-Based)Nanjing Vazyme Medical Technology Co.STAGE 2
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90Finecare 2019-nCov Antigen Test
Guangzhou Wondfo Biotech Co., Ltd.STAGE 2
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91Vazyme Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antigen Detection Kit (Colloidal Gold-Based)Nanjing Vazyme Medical Technology Co.STAGE 2
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92FLOWFLEX™ SARS-COV-2 ANTIGEN RAPID TESTACON BIOTECH (HANGZHOU) CO., LTDSTAGE 2
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93V-CODE ENCODE SARS-COV-2 Antigen Rapid Test DeviceZhuhai Encode Medical Engineering Co., LtdSTAGE 2
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94COVID-19 SALIVARY ANTIGEN RAPID TEST KIT (COLLOIDAL GOLD)Jiangsu Konsung Bio-Medical Science and Technology Co., LtdSTAGE 2
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95SARS-CoV-2 Antigen Detection Kit (colloidal gold method)
Xiamen Jiqing Biomedical Technology Co., LtdSTAGE 2
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96SARS-CoV-2 IgG II CLIA MicroparticlesAutobio Diagnostics Co., LtdSTAGE 2
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97SARS-CoV-2 IgM II CLIA MicroparticlesAutobio Diagnostics Co., LtdSTAGE 2
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98ACCESS SARS-CoV-2 IgGBeckman Coulter, IncSTAGE 2
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99SARS-CoV-2 NAb Q CLIA MicroparticlesAutobio Diagnostics Co., LtdSTAGE 2
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100Rapid test PBCheck COVID-19 AgPrecision Biosensor IncSTAGE 2
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101SCoV-2 Ag Detect Rapid TestInBios International, Inc.STAGE 2
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102Novel Coronavirus (SARS-CoV-2) Antigen rapid test CassetteHangzhou Realy Tech Co., Ltd.STAGE 2
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103SARS-CoV-2 AntigenDia.Pro Diagnostic Bioprobes S.r.l.STAGE 2
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104Novel Coronavirus Antigen Detection Kit (Colloidal Gold)New Gene (Hangzhou) Bioengineering Co., LtdSTAGE 2
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105SARS-CoV-2 IgG/IgM Kit (Colloidal Gold)Goldsite Diagnostics IncSTAGE 2
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