PRODUCT EVALUATION STATUS ANTIGEN TEST KITS

Updated as of July 30, 2021

NoProduct NameManufacturerStatus
1AFIAS COVID-19 AgBoditech Med Inc.ONGOING
2BD Veritor System for Rapid Detection of SARS-CoV-2Becton, Dickinson And Company / Web Industries, Inc.ONGOING
3VivaDiagTM SARS-CoV-2 Ag Rapid TestVivachek Biotech Hangzhou Co. Ltd.ONGOING
4SAVANT™ New Coronavirus (SARS-CoV-2) N Protein Detection Kit (Fluorescence Immunochromatography)Beijing Savant Biotechnology Co. LtdPENDING
5SARS-CoV-2 Antigen Rapid Test Kit (COLLOIDAL GOLD IMMUNOCHROMATOGRAPHY)Beijing Lepu Medical Technology Co., Ltd.PENDING
6COVID-19 Antigen Rapid TestHangzhou Alltest Biotech Co., Ltd.PENDING
7COVID-19 Antigen Rapid Test (Latex)Joinstar Biomedical Technology Co., LtdPENDING
8SARS-CoV-2 Rapid Antigen TestSD Biosensor Inc. (Roche)PENDING
9SARS-CoV-2 (COVID-19) Antigen Rapid Detection KitTsinglight (Wuhan) Biotechnology Co., Ltd.PENDING
10(2019-nCov) New Coronavirus Antigen Test (Colloidal GoldNantong Diagnos Biotechnology Co LtdPENDING
11ACCEL ELISA COVID-19Plexence, Inc.PENDING
12Sofia 2 Flu + SARS Antigen FIAQuidel CorporationPENDING
13SGTi-flex COVID-19 AgSugentech Inc.PENDING
14Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method)Guanzhou Wondfo Biotech Co., Ltd.PENDING
15Camtech COVID-19 Antigen Rapid TestCamtech Biomedical Pte. LtdPENDING
16Helix i-SARS-CoV-2 Ag Rapid Test (Lateral Flow Chromatographic Immunoassay)Helix, Inc.PENDING
17CareStart COVID-19 Antigen testAccess Bio, Inc.PENDING
18PARTNERS COVID-19 Antigen Rapid Test CassetteHangzhou Biotest Biotech Co., Ltd.PENDING
19SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold)Joysbio(Tianjin) Biotechnology Co., Ltd.PENDING
20GENEDIA W COVID-19 AGGreen Cross Medical SciencePENDING
21COVID-19 and Influenza A+B Antigen Combo Rapid TestHangzhou Alltest Biotech Co., Ltd.PENDING
22SARS-CoV-2 Antigen Test Kit (Colloidal Gold)Genrui Biotech Inc.PENDING
23Novel coronavirus (2019-nCoV) antigen detection kit (latex method)Beijing Jinwofu Bioengineering Technology Co., Ltd.PENDING
24VivaDiag SARS-CoV-2 Ag FIA Test VID44Vivachek Biotech Hangzhou Co. Ltd.PENDING
25Standard™ F COVID-19 Ag FIASd Biosensor Inc.PENDING
26InnoScreen COVID-19 Antigen Rapid Test DeviceInnovation Scientific Pty LtdPENDING
27VSTRIP COVID-19 Antigen Rapid TestPanion & Bf Biotech Inc.PENDING
28Dynamiker SARS-CoV-2 Ag Rapid TestDynamiker Biotechnology (Tianjin) Co., Ltd.PENDING
29COVID-19 Antigen Rapid Test (Colloidal Gold)Joinstar Biomedical Technology Co., LtdPENDING
30VTRUST COVID-19 (SARS-COV-2) Antigen Rapid TestTaidoc Technology Corporation Wugu FactoryPENDING
31COVID-19 Antigen TestArtron Laboratories Inc.PENDING
32CareStart COVID-19 Antigen testAccess Bio Korea, Inc.PENDING
33Panbio COVID-19 Ag Rapid Test Device (NASAL)Abbot Rapid Diagnostics Jena GmbhPENDING
342019-nCoV Ag Test (Latex Chromatography Assay)Innovita (Tangshan) Biological Technology Co., Ltd.PENDING
35FORA COVID-19 Antigen Rapid TestTaidoc Technology Corporation Wugu FactoryPENDING
36Humasis COVID-19 Ag TestHumasis Co., Ltd.PENDING
37OnSite® COVID-19 Ag Point of care testCTK Biotech Inc.PENDING
38VivaDiag™ PRO SARS-CoV-2 Ag Rapid TestVivachek Biotech Hangzhou Co. Ltd.PENDING
39VITROS Immunodiagnostic Products SARSCoV- 2 Antigen Reagent Pack (619 9941)Ortho-Clinical Diagnostics, Inc.PENDING
40Elecsys SARS-CoV-2 Antigen Test E1GRoche Diagnostic GmbhPENDING
41SURGITECH COVID-19 Ag Rapid TestCTK Biotech Inc.PENDING
42Aria COVID-19 Ag Rapid Test (Nasopharyngeal Swab)CTK Biotech Inc.PENDING
43Cellex qSARS-CoV-2 Antigen Rapid Test (Lateral Flow Chromatographic Immunoassay)Cellex Inc.PENDING
44PanbioTM COVID-19 Ag Rapid Test Device (NASAL)Abbott Diagnostics Korea Inc.PENDING
45MAGLUMI SARS-CoV-2 Ag (CLIA)Shenzhen New Industries Biomedical Engineering Co., Ltd.PENDING
46SARS-COV-2 ANTIGEN ASSAY KIT (COLLOIDAL GOLD METHOD)Zybio, Inc.PENDING
47SARS-CoV-2 AntigenDia.Pro Diagnostic Bioprobes S.r.lPENDING
48Elecsys SARS-CoV-2 Antigen Test (Catalog No. 09345299190)Roche Diagnostics GmbH,PENDING
49COVID-19 SALIVARY ANTIGEN RAPID TEST KIT (COLLOIDAL GOLD)Jiangsu Konsung Bio-Medical Science and Technology Co., LtdPENDING
50V-CODE ENCODE SARS-COV-2 Antigen Rapid Test DeviceZhuhai Encode Medical Engineering Co., LtdPENDING
51VivaDiag SARS-CoV-2 Ag FIA Test VID44VivaChek Biotech (Hangzhou) Co., Ltd.PENDING
52COVID-19 Antigen Test Kit (Dry Fluorescence Immunoassay)ARTRON LABORATORIES INC.PENDING
53HANGZHOU ALLTEST COVID-19 ANTIGEN RAPID TESTHangzhou AllTest Biotech Co., LtdPENDING
54COVID-19 and Influenza A+B Antigen Combo Rapid TestHangzhou AllTest Biotech Co., LtdPENDING
55CHORUS SARS-CoV-2 Antigen Code: 81410DIESSE Diagnostica Senese S.p.APENDING
56Asan Easy Test® COVID-19 Ag (Specimen: Nasopharyngeal Swab)Asan Pharmaceutical Co., Ltd.PENDING
57Dynamiker SARS-CoV-2 Ag Rapid Test (Specimen: Saliva)Dynamiker Biotechnology (Tianjin) Co., Ltd.PENDING
58SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) SPECIMEN- ORAL FLUIDS: SALIVAJOYSBIO(Tianjin) Biotechnology Co., Ltd.PENDING
59ORIGHT COVID-19 Antigen Rapid Test CassetteHangzhou Biotest Biotech Co., Ltd.PENDING
60HEALGEN® Coronavirus Ag Rapid Test Cassette (Swab)Healgen Scientific Limited Liability CompanyPENDING
61JOYSBIO SARS-COV-2 Antigen Rapid Test Kit (Colloidal Gold)JOYSBIO (Tianjin) Biotechnology Co., Ltd.PENDING
62CLUNGENE® COVID-19 Antigen Rapid Test CassetteHangzhou Clongene Biotech Co. LtdPENDING
63SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) SPECIMEN- ORAL FLUIDS: SALIVAJOYSBIO(Tianjin) Biotechnology Co., Ltd.PENDING
64NanoCare™ COVID-19 Antigen (Ag) KitNanoBiolife, IncPENDING
65ENIMMUNE SPEEDY COVID-19 AG RAPID TESTFirstep Bioresearch, Inc.PENDING
66Standard Q COVID-19 Ag Test (Nasal swab)SD Biosensor, Inc.PENDING
67SARS-CoV-2 & Influenza A/B Antigen Combo Rapid Test Kit (Medomics)Jiangsu Medomics medical technology Co., LtdPENDING
68VAZYME Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antigen Detection Kit (Colloidal Gold-Based)Nanjing Vazyme Medical Technology Co. LtdPENDING
69AllCheck COVID 19 AgCALTH lNCPENDING
70FUJIFILM COVID-19 Ag TestFUJIFILM CORPORATIONPENDING
71Clungene COVID-19 Antigen Rapid Test CassetteHangzhou Clongene Biotech Co., Ltd.PENDING
72Hangzhou Alltest COVID-19 Antigen Rapid Test (Nasopharyngeal Swab)Hangzhou AllTest Biotech Co., LtdPENDING
73SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography)Beijing Lepu Medical Technology Co., LtdPENDING
74COVID-19 Antigen Rapid Test Cassette (Saliva)Hangzhou Biotest Biotech Co., Ltd.PENDING
75SARS-CoV-2 Rapid Antigen Test NasalSD Biosensor, IncPENDING
76Dynamiker SARS-CoV-2 Ag Rapid Test (DNK-1425-1)Dynamiker Biotechnology (Tianjin) Co. LtdPENDING
77Novel Coronavirus(2019-nCoV) Antigen Rapid TestBioscience (Tianjin) Diagnostic Technology Co.,LtdPENDING
78COVID-19 Antigen Rapid Test (Oral Fluid)Hangzhou AllTest Biotech Co., Ltd.PENDING
79Rapid Response® COVID-19 Antigen Rapid Test DeviceBTNX INC.PENDING
80CLEAREPI™ SARS-CoV-2 COVID Detect Antigen Rapid TestBiolidics LtdPENDING
81SARS CoV-2 Antigen Rapid Test Kit (Saliva Test)Ningbo Home Test Bio-technology Co.,Ltd.PENDING
82Wondfo 2019-nCoV Antigen Test (Lateral flow)Guangzhou Wondfo Biotech Co., Ltd.PENDING
83CareUs Covid-19 AntigenWELLS BIO, INC.PENDING
84QuickVue SARS Antigen TestQuidel Corporation- 10165 McKellar Court, San Diego, CA 92121 USAPENDING