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  • Fact Sheet for Healthcare Providers Lumiradx UK Ltd., LumiraDx SARS-CoV-2 RNA STAR Complete
    United States. Food and Drug Administration
    2021-02-09
  • Fact Sheet for Healthcare Providers: Access Bio, Inc., 'CareStart'™ COVID-19 Antigen
    United States. Food and Drug Administration
    2021-02-01
  • Fact Sheet for Healthcare Providers: BioFire Diagnostics, LLC, BioFire® Respiratory Panel 2.1-EZ (RP2.1-EZ)
    United States. Food and Drug Administration
    2020-11-22
  • Fact Sheet for Healthcare Providers: Celltrion USA, Inc., Sampinute™ 'COVID-19 Antigen MIA'
    United States. Food and Drug Administration
    2020-10-23
  • Fact Sheet for Healthcare Personnel: Zoe-Ann Decontamination System for Decontaminating Compatible N95 Respirators
    United States. Food and Drug Administration
    2020-10-20
  • Fact Sheet for Healthcare Providers: Abbott Laboratories, AdviseDx SARS-CoV-2 IgM
    United States. Food and Drug Administration
    2020-10-09
  • Fact Sheet for Healthcare Providers: Beckman Coulter, Inc., Access SARS‐CoV‐2 IgM
    United States. Food and Drug Administration
    2020-10-08
  • Fact Sheet for Healthcare Providers: Genalyte, Inc., Maverick SARS-CoV-2 Multi-Antigen Serology Panel v2
    United States. Food and Drug Administration
    2020-10-08
  • Fact Sheet for Healthcare Providers: ePlex® Respiratory Pathogen Panel 2, GenMark Diagnostics, Inc.
    United States. Food and Drug Administration
    2020-10-07
  • Fact Sheet for Healthcare Providers: University of California, Los Angeles (UCLA), UCLA SwabSeq COVID-19 Diagnostic Platform
    United States. Food and Drug Administration
    2020-10-06
  • Fact Sheet for Healthcare Providers: Zeus Scientific, Inc., ZEUS ELISA SARS-CoV-2 IgG Test System
    United States. Food and Drug Administration
    2020-10-06
  • Fact Sheet for Healthcare Providers: Seasun Biomaterials Inc, AQ-TOP COVID-19 Rapid Detection Kit PLUS
    United States. Food and Drug Administration
    2020-10-05
  • Fact Sheet for Healthcare Providers: Quidel Corporation, Sofia 2 Flu + SARS Antigen FIA
    United States. Food and Drug Administration
    2020-10-02
  • Fact Sheet for Healthcare Providers: Thermo Fisher Scientific, OmniPATH COVID-19 Total Antibody ELISA Test
    United States. Food and Drug Administration
    2020-10-02
  • Fact Sheet for Healthcare Providers: DetectaChem Inc, MobileDetect Bio BCC19 Test Kit
    United States. Food and Drug Administration
    2020-10-02
  • Fact Sheet for Healthcare Providers: Cepheid, Xpert Xpress SARS-CoV-2/Flu/RSV
    United States. Food and Drug Administration
    2020-10-01
  • Fact Sheet for Healthcare Providers: Tempus Labs, Inc., iC SARS-CoV2 Test
    United States. Food and Drug Administration
    2020-10-01
  • Fact Sheet for Healthcare Providers: Access IL-6 - Beckman Coulter, Inc.
    United States. Food and Drug Administration
    2020-10-01
  • Fact Sheet for Healthcare Providers: Nirmidas Biotech, Inc., Nirmidas COVID-19 (SARS-CoV-2) IgM/IgG Antibody Detection Kit
    United States. Food and Drug Administration
    2020-09-29
  • Fact Sheet for Healthcare Providers: NanoEntek America, Inc., FREND COVID-19 total Ab
    United States. Food and Drug Administration
    2020-09-29
  • Fact Sheet for Healthcare Providers: CENTOGENE US, LLC, CentoSure SARS-CoV-2 RT-PCR Assay
    United States. Food and Drug Administration
    2020-09-29
  • Fact Sheet for Healthcare Providers: DiaSorin Inc., LIAISON SARS-CoV-2 IgM
    United States. Food and Drug Administration
    2020-09-29
  • Fact Sheet for Healthcare Providers: Genetrack Biolabs, Inc., Genetrack SARS-CoV-2 Molecular Assay
    United States. Food and Drug Administration
    2020-09-25
  • Fact Sheet for Healthcare Providers: QUOTIENT SUISSE SA, MosaiQ COVID-19 Antibody Magazine
    United States. Food and Drug Administration
    2020-09-25
  • Fact Sheet for Healthcare Providers: Emergency Use of the COViage System During the COVID-19 Pandemic
    United States. Food and Drug Administration
    2020-09-24
  • Fact Sheet for Healthcare Providers: Emergency Use of the Duke University COVIAGE
    United States. Food and Drug Administration
    2020-09-24
  • Fact Sheet for Healthcare Providers: Clear Labs, Inc., Clear Dx SARS-CoV-2 Test
    United States. Food and Drug Administration
    2020-09-23
  • Fact Sheet for Healthcare Providers: JIANGSU WELL BIOTECH CO., LTD., Orawell IgM/IgG Rapid Test
    United States. Food and Drug Administration
    2020-09-23
  • Fact Sheet for Healthcare Providers: Azure Biotech Inc., Assure COVID-19 IgG/IgM Rapid Test Device
    United States. Food and Drug Administration
    2020-09-23
  • Fact Sheet for Healthcare Providers: Vela Operations Singapore Pte. Ltd., Virokey SARS-CoV-2 RT-PCR Test v2.0
    United States. Food and Drug Administration
    2020-09-22
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