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  • Fact Sheet for Healthcare Providers: DTPM COVID-19 RT-PCR Test - Tide Laboratories, LLC
    United States. Food and Drug Administration
    2020-06-10
  • Fact Sheet for Healthcare Providers: ExProbe SARS-CoV-2 Testing Kit -- TBG Biotechnology Corp.
    United States. Food and Drug Administration
    2020-06-10
  • Fact Sheet for Healthcare Providers: EURORrealTime SARS-CoV-2 - EUROIMMUN US Inc
    United States. Food and Drug Administration
    2020-06-09
  • Fact Sheet for Healthcare Providers: Illumina COVIDSeq Test -- Illumina, Inc.
    United States. Food and Drug Administration
    2020-06-09
  • 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: Dimension EXL SARS-CoV-2 Total Antibody Assay (CV2T); Siemens Healthcare Diagnostics Inc
    United States. Food and Drug Administration
    2020-06-08
  • Fact Sheet for Healthcare Providers: Genetron SARS-CoV-2 RNA Test -- Genetron Health (Beijing) Co., Ltd.
    United States. Food and Drug Administration
    2020-06-05
  • Fact Sheet for Healthcare Providers: Vibrant COVID-19 Ab Assay -- Vibrant America Clinical Labs
    United States. Food and Drug Administration
    2020-06-04
  • 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: Emergency Use of the Patient Isolation Transport Unit (PITU)
    United States. Food and Drug Administration
    2020-05-08
  • Fact Sheet for Healthcare Providers: Emergency Use of a Protective Barrier Enclosure During the COVID-19 Pandemic
    United States. Food and Drug Administration
    2020-05-01
  • Fact Sheet for Healthcare Providers: Emergency Use of the B. Braun Space and Outlook Pumps During the COVID-19 Pandemic
    United States. Food and Drug Administration
    2020-04-11
  • Fact Sheet for Healthcare Providers: New York SARS-CoV-2 Real-Time RT-PCR Diagnostic Panel
    United States. Food and Drug Administration
    2020-03-15
  • Fact Sheet for Healthcare Providers: Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Tests [SARS-CoV-2 RNA DETECTR Assay]
    United States. Food and Drug Administration
    2020?
  • Fact Sheet for Healthcare Providers: Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Tests [Boston Heart COVID-19 RT-PCR Test]
    United States. Food and Drug Administration
    2020?
  • Fact Sheet for Healthcare Providers: Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Tests [Acupath COVID-19 Real-Time (RT-PCR) Assay]
    United States. Food and Drug Administration
    2020?
  • Fact Sheet for Healthcare Providers Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Tests [CRSP SARS-CoV-2 Real-Time Reverse Transcriptase (RT) PCR Diagnostic Assay]
    United States. Food and Drug Administration
    2020?
  • Fact Sheet for Healthcare Providers: Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Tests [BMC-CReM COVID-19 Test]
    United States. Food and Drug Administration
    2020?
  • Fact Sheet for Healthcare Providers: Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Tests [Gene By Gene SARS-CoV-2 Detection Test]
    United States. Food and Drug Administration
    2020?
  • Fact Sheet for Healthcare Providers: Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Tests [Pro-AmpRT SARS-CoV-2 Test]
    United States. Food and Drug Administration
    2020?
  • Fact Sheet for Healthcare Providers: Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Tests [Helix COVID-19 NGS Test]
    United States. Food and Drug Administration
    2020?
  • Fact Sheet for Healthcare Providers: Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Tests [Alpha Genomix TaqPath SARS-CoV-2 Combo Assay]
    United States. Food and Drug Administration
    2020
  • Fact Sheet for Healthcare Providers: REGIOCIT: A Replacement Solution that Contains Citrate for Regional Citrate Anticoagulation (RCA) of the Extracorporeal Circuit
    United States. Food and Drug Administration
    2020?
  • Fact Sheet for Healthcare Providers: Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Tests [GWU COVID-19 RT-PCR Test]
    United States. Food and Drug Administration
    2020?
  • Fact Sheet for Healthcare Providers: Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Tests [Solaris Multiplex 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 [Texas Department of State Health Services (DSHS) 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 [Guardant-19 Test]
    United States. Food and Drug Administration
    2020?
  • 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: 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?
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