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  • Fact Sheet for Healthcare Providers: DetectaChem Inc, MobileDetect Bio BCC19 Test Kit
    United States. Food and Drug Administration
    2020-10-02
  • Updated Evidence to Support the Emergency Use of COVID-19 Convalescent Plasma - As of 9/23/2020
    United States. Food and Drug Administration
    2020-09-23
  • 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: JIANGSU WELL BIOTECH CO., LTD., Orawell IgM/IgG Rapid Test
    United States. Food and Drug Administration
    2020-09-23
  • Fact Sheet for Healthcare Providers: Quadrant Biosciences Inc., Clarifi COVID-19 Test Kit
    United States. Food and Drug Administration
    2020-09-22
  • Fact Sheet for Healthcare Providers: Kimforest Enterprise Co., Ltd, KimForest SARS-CoV-2 Detection Kit v1
    United States. Food and Drug Administration
    2020-09-21
  • 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: Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Tests [SARS-CoV-2 Mass Array Test]
    United States. Food and Drug Administration
    2020?
  • 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: 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: Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Tests [Akron Children's Hospital SARS-CoV-2 Assay]
    United States. Food and Drug Administration
    2020?
  • Fact Sheet for Healthcare Providers: Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Tests [Aeon Global Health SARS-CoV-2 Assay]
    United States. Food and Drug Administration
    2020?
  • Fact Sheet for Healthcare Providers: CentoFast-SARS-COV-2 RT-PCR Assay -- CENTOGENE US, LLC
    United States. Food and Drug Administration
    2020-07-01
  • Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency: Guidance for Industry, Investigators, and Institutional Review Boards
    United States. Food and Drug Administration
    2020-12-04
  • 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: Roche Molecular Systems, Inc., cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test for use on the cobas Liat System
    United States. Food and Drug Administration
    2020-09-14
  • 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: Visby Medical, Inc., Visby Medical COVID-19
    United States. Food and Drug Administration
    2020-09-16
  • 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: Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Tests [Alimetrix SARS-CoV-2 RT-PCR Assay]
    United States. Food and Drug Administration
  • Enforcement Policy for Modifications to FDA-Cleared Molecular Influenza and RSV Tests During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for Industry and Food and Drug Administration Staff
    United States. Food and Drug Administration
    2020-10
  • 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: 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: Abbott Laboratories, AdviseDx SARS-CoV-2 IgM
    United States. Food and Drug Administration
    2020-10-09
  • FDA Strategy for the Safety of Imported Food
    United States. Food and Drug Administration
    2019-02
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