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  • Importing Respirators for Health Care Personnel Use During COVID-19 Pandemic
    United States. Food and Drug Administration
    Verbeten, John; Powers, John R., Jr.
    2020-06-23?
  • Fact Sheet for Healthcare Providers: TBG Biotechnology Corp., TBG SARS-CoV-2 IgG/IgM Rapid Test Kit
    United States. Food and Drug Administration
    2020-08-31
  • Fact Sheet for Healthcare Providers: University of Arizona Genetics Core for Clinical Services, COVID-19 ELISA pan-Ig Antibody Test
    United States. Food and Drug Administration
    2020-08-31
  • Fact Sheet for Healthcare Providers: Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Tests [MiraDx SARS-CoV-2 RT-PCR]
    United States. Food and Drug Administration
  • Fact Sheet for Healthcare Providers: T2 Biosystems, Inc., T2SARS-CoV-2 Panel
    United States. Food and Drug Administration
    2020-08-31
  • Fact Sheet for Healthcare Providers: Mammoth Biosciences, Inc., SARS-CoV-2 DETECTR Reagent Kit
    United States. Food and Drug Administration
    2020-08-31
  • Device: Inform Diagnostics SARS-CoV-2 RT-PCR Assay
    United States. Food and Drug Administration
    2020-06-26
  • Fact Sheet for Healthcare Providers: Bioeksen R&D Technologies Ltd., Bio-Speedy Direct RT-qPCR SARS-CoV-2
    United States. Food and Drug Administration
    2020-09-02
  • 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: Quidel Corporation, Sofia 2 Flu + SARS Antigen FIA
    United States. Food and Drug Administration
    2020-10-02
  • Fact Sheet for Healthcare Providers: Shenzhen New Industries Biomedical Engineering Co., Ltd. (SNIBE), MAGLUMI 2019-nCoV IgM/IgG
    United States. Food and Drug Administration
    2020-09-14
  • 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
  • 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: Clear Labs, Inc., Clear Dx SARS-CoV-2 Test
    United States. Food and Drug Administration
    2020-09-23
  • 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: GK Pharmaceuticals Contract Manufacturing Operations, GK ACCU-RIGHT SARS-CoV-2 RT-PCR KIT
    United States. Food and Drug Administration
    2020-09-18
  • 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: Thermo Fisher Scientific, OmniPATH COVID-19 Total Antibody ELISA Test
    United States. Food and Drug Administration
    2020-10-02
  • Fact Sheet for Healthcare Providers: Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Tests [UMass Molecular Virology Laboratory 2019-nCoV rRT-PCR Dx Panel]
    United States. Food and Drug Administration
  • FDA Briefing Document: Development, Authorization and Licensure of Vaccines to Prevent COVID-19
    United States. Food and Drug Administration
    2020-10-22
  • 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: Zeus Scientific, Inc., ZEUS ELISA SARS-CoV-2 IgG Test System
    United States. Food and Drug Administration
    2020-10-06
  • 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?
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