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FDA is hereby announcing the following Authorizations for molecular diagnostic and antigen tests for COVID-19, excluding multi-analyte tests:β[3]
Visby Medical, Inc.'s Visby Medical COVID-19, issued September 16, 2020;
GK Pharmaceuticals Contract Manufacturing Operations' GK ACCU-RIGHT SARS-CoV-2 RT-PCR KIT, issued September 18, 2020;
KimForest Enterprise Co., Ltd.'s KimForest SARS-CoV-2 Detection Kit v1, issued September 21, 2020;
Vela Operations Singapore Pte. Ltd.'s ViroKey SARS-CoV-2 RT-PCR Test v2.0, issued September 22, 2020;
Quadrant Biosciences Inc.'s Clarifi COVID-19 Test Kit, issued September 22, 2020;
Clear Labs, Inc.'s Clear Dx SARS-CoV-2 Test, issued September 23, 2020;
Genetrack Biolabs, Inc.'s Genetrack SARS-CoV-2 Molecular Assay, issued September 25, 2020;
National Jewish Health's SARS-CoV-2 MassArray Test, issued September 29, 2020;
Akron Children's Hospital's Akron Children's Hospital SARS-CoV-2 Assay, issued September 29, 2020;
CENTOGENE US, LLC's CentoSure SARS-CoV-2 RT-PCR Assay, issued September 29, 2020;
Aeon Global Health's Aeon Global Health SARS-CoV-2 Assay, issued September 30, 2020;
Alimetrix, Inc.'s Alimetrix SARS-CoV-2 RT-PCR Assay, issued September 30, 2020;
Tempus Labs, Inc.'s iC SARS-CoV2 Test, issued October 1, 2020;
UMass Memorial Medical Center's UMass Molecular Virology Laboratory 2019-nCoV rRT-PCR Dx Panel, issued October 1, 2020;
SEASUN BIOMATERIALS, Inc.'s AQ-TOP COVID-19 Rapid Detection Kit PLUS, issued October 5, 2020;
University of California, Los Angeles's (UCLA's) UCLA SwabSeq COVID-19 Diagnostic Platform, issued October 6, 2020;
Access Bio, Inc.'s CareStart COVID-19 Antigen, issued October 8, 2020;
LumiraDx UK Ltd.'s LumiraDx SARS-CoV-2 RNA STAR Complete, issued October 14, 2020;
Celltrion USA, Inc.'s Sampinute COVID-19 Antigen MIA, issued October 23, 2020;
Agena Bioscience, Inc.'s MassARRAY SARS-CoV-2 Panel, issued October 26, 2020;
Lucira Health, Inc.'s Lucira COVID-19 All-In-One Test Kit, issued November 17, 2020;
Gravity Diagnostics, LLC's Gravity Diagnostics SARS-CoV-2 RT-PCR Assay, issued November 23, 2020;
Cepheid's Xpert Omni SARS-CoV-2, issued November 27, 202;
Luminostics, Inc.'s Clip COVID Rapid Antigen Test, issued December 7, 2020;
Laboratory Corporation of America's Pixel by LabCorp COVID-19 Test Home Collection Kit, issued December 9, 2020;
ResearchDx, Inc., DBA Pacific Diagnostics' PacificDx Covid-19 Test, issued December 11, 2020;
RCA Laboratory Services LLC dba GENETWORx's GENETWORx Covid-19 Nasal Swab Test, issued December 15, 2020;
Ellume Limited's Ellume COVID-19 Home Test, issued December 15, 2020;
Abbott Diagnostics Scarborough, Inc.'s BinaxNOW COVID-19 Ag Card Home Test, issued December 16, 2020;
Materials and Machines Corporation of America's (DBA MatmaCorp, Inc.) MatMaCorp COVID-19 2SF Test, issued December 17, 2020;
Quidel Corporation's QuickVue SARS Antigen Test, issued December 18, 2020;
Quidel Corporation's Solana SARS-CoV-2 Assay, issued December 23, 2020;
Cepheid's Xpert Xpress SARS-CoV-2 DoD, issued December 23, 2020;
Quanterix Corporation's Simoa SARS-CoV-2 N Protein Antigen Test, issued January 5, 2021;
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Ortho Clinical Diagnostics, Inc.'s VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack used in combination with the VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Calibrator, issued January 11, 2021;
SML GENETREE Co., Ltd.'s Ezplex SARS-CoV-2 G Kit, issued January 13, 2021;
Bio-Rad Laboratories, Inc.'s Bio-Rad Reliance SARS-CoV-2 RT-PCR Assay Kit, issued January 15, 2021;
Ambry Genetics Laboratory's Ambry COVID-19 RT-PCR Test, issued January 22, 2021;
Clinomics USA Inc.'s Clinomics TrioDx RT-PCR COVID-19 Test, issued February 4, 2021;
Visby Medical, Inc.'s Visby Medical COVID-19 Point of Care Test, issued February 8, 2021;
Grifols Diagnostic Solutions Inc.'s Procleix SARS-CoV-2 Assay, issued February 10, 2021;
Assurance Scientific Laboratories' Assurance SARS-CoV-2 Panel DTC, issued February 13, 2021; and
Gravity Diagnostics, LLC's Gravity Diagnostics SARS-CoV-2 RT-PCR for use with DTC kits, issued February 13, 2021.