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  • Fact Sheet for Healthcare Providers: BayCare Laboratories, LLC, BayCare SARS-CoV-2 RT PCR Assay
    United States. Food and Drug Administration
    2020-08-31
  • Fact Sheet for Healthcare Providers: Sugentech, Inc., SGTi-flex COVID-19 IgG
    United States. Food and Drug Administration
    2020-09-03
  • Fact Sheet for Healthcare Providers: OPTOLANE Technologies, Inc., Kaira 2019-nCoV Detection Kit
    United States. Food and Drug Administration
    2020-09-01
  • Fact Sheet for Healthcare Providers: Roche Molecular Systems, Inc., cobas SARS-CoV-2 & Influenza A/B
    United States. Food and Drug Administration
    2020-09-03
  • Vaccines and Related Biological Products Advisory Committee Meeting: Pfizer-BioNTech COVID-19 Vaccine
    United States. Food and Drug Administration
    2020-12-10
  • Fact Sheet for Healthcare Providers: BioCheck Inc., BioCheck SARS-CoV-2 IgG Antibody Test Kit
    United States. Food and Drug Administration
    2020-09-09
  • Fact Sheet for Healthcare Providers: Verily Life Sciences, Verily COVID-19 RT-PCR Test
    United States. Food and Drug Administration
    2020-09-08
  • Fact Sheet for Healthcare Providers: Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Tests [MD Anderson High-Throughput SARS-CoV-2 RT-PCR Assay]
    United States. Food and Drug Administration
  • Fact Sheet for Healthcare Providers: QDx Pathology Services -- QDx SARS-CoV-2 Assay
    United States. Food and Drug Administration
    2020-08-25
  • Fact Sheet for Healthcare Providers: BIOCAN DIAGNOSTICS INC, Tell Me Fast Novel Coronavirus (COVID-19) IgG/IgM Antibody Test
    United States. Food and Drug Administration
    2020-08-25
  • Fact Sheet for Healthcare Providers: DxTerity Diagnostics, Inc., DxTerity SARS-CoV-2 RT-PCR CE Test
    United States. Food and Drug Administration
    2020-08-28
  • Fact Sheet for Healthcare Providers: Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Tests [PCL SARS-CoV-2 Real-Time RT-PCR Assay]
    United States. Food and Drug Administration
  • Fact Sheet for Healthcare Providers: Abbott Diagnostics Scarborough, Inc. BinaxNOW™ COVID-19 Ag Card
    United States. Food and Drug Administration
    2020-08-26
  • Fact Sheet for Healthcare Providers: Fluidigm Corporation Advanta Dx SARS-CoV-2 RT-PCR Assay
    United States. Food and Drug Administration
    2020-08-25
  • Fact Sheet for Healthcare Providers: LumiraDx UK Ltd.; LumiraDx SARS-CoV-2 Antigen (Ag) Test
    United States. Food and Drug Administration
    2020-08-18
  • Fact Sheet for Healthcare Providers: Diazyme Laboratories, Inc.; Diazyme DZ-Lite SARS-CoV-2 IgM CLIA Kit
    United States. Food and Drug Administration
    2020-08-17
  • Fact Sheet for Health Care Providers: Emergency Use Authorization (EUA) of COVID-19 Convalescent Plasma for Treatment of COVID-19 in Hospitalized Patients
    United States. Food and Drug Administration
    2020-08-23
  • Fact Sheet for Healthcare Personnel: Nova2200 for Decontaminating Compatible N95 Respirators
    United States. Food and Drug Administration
    2020-08-20
  • Fact Sheet for Healthcare Providers: BioCheck Onc.; BioCheck SARS-CoV-2 IgG and IgM Combo Test
    United States. Food and Drug Administration
    2020-08-17
  • Fact Sheet for Healthcare Providers: ZhuHai Sinochips Bioscience Co., Ltd; COVID-19 Nucleic Acid RT-PCR Test Kit
    United States. Food and Drug Administration
    2020-08-17
  • Fact Sheet for Healthcare Providers: 'Hangzhou' Biotest Biotech Co., Ltd.; RightSign™ COVID-19 IgG/IgM Rapid Test Cassette
    United States. Food and Drug Administration
    2020-06-04
  • Fact Sheet for Healthcare Providers: HDPCR™ SARS-CoV-2 Assay -- ChromaCode Inc.
    United States. Food and Drug Administration
    2020-06-09
  • Fact Sheet for Healthcare Providers: Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Tests [Texas Department of State Health Services (DSHS) SARS-CoV-2 Assay]
    United States. Food and Drug Administration
    2020?
  • Fact Sheet for Healthcare Providers: DxTerity SARS-CoV-2 RT-PCR Test
    United States. Food and Drug Administration
    2020-08-21
  • Fact Sheet for Healthcare Providers: Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Tests [Guardant-19 Test]
    United States. Food and Drug Administration
    2020?
  • Development and Licensure of Vaccines to Prevent COVID-19: Guidance for Industry
    United States. Food and Drug Administration
    2020-06
  • Revocation of EUA200179
    United States. Food and Drug Administration
    Hinton, Denise M.
    2020-06-16
  • [Letter Revoking Emergency Use Authorization (EUA) of Chloroquine Phosphates Supplied from the Strategic National Stockpile for Treatment of COVID-19 in Certain Hospitalized Patients]
    United States. Food and Drug Administration
    2020-06-15
  • Frequently Asked Questions on the Revocation of the Emergency Use Authorization for Hydroxychloroquine Sulfate and Chloroquine Phosphate
    United States. Food and Drug Administration
    2020-06-19
  • Fact Sheet for Healthcare Personnel: Technical Safety Services 20-CS Decontamination System for Decontaminating Compatible N95 Respirators
    United States. Food and Drug Administration
    2020-06-13
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