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  • Fact Sheet for Healthcare Providers: Siemens Healthcare Diagnostics Inc. ADVIA Centaur® SARS-CoV-2 IgG (COV2G)
    United States. Food and Drug Administration
    2020-07-31
  • Fact Sheet for Healthcare Providers: Siemens Healthcare Diagnostics Inc. Atellica® IM SARS-CoV-2 IgG (COV2G)
    United States. Food and Drug Administration
    2020-07-31
  • Fact Sheet for Healthcare Providers: Xiamen Zeesan Biotech Co., Ltd. Sars-Cov-2 Test Kit (Real-Time Pcr)
    United States. Food and Drug Administration
    2020-07-31
  • Letter of Authorization: UCSD RC SARS-CoV-2 Assay
    United States. Food and Drug Administration
    Hinton, Denise M.
    2020-07-31
  • Fact Sheet for Healthcare Providers: Clinical Reference Laboratory, Inc. - CRL Rapid Response
    United States. Food and Drug Administration
    2020-07-30
  • Fact Sheet for Healthcare Providers: Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Tests [SNL-NM 2019 Ncov Real-Time RT-PCR Diagnostic Assay]
    United States. Food and Drug Administration
    2020-07-27?
  • Fact Sheet for Healthcare Providers: Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Tests [Lilly SARS-CoV-2 Assay]
    United States. Food and Drug Administration
    2020-07-27?
  • Fact Sheet for Healthcare Providers: MSU System for Decontaminating Compatible N95 Respirators
    United States. Food and Drug Administration
    2020-07-24
  • Fact Sheet for Healthcare Providers: Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Tests [Helix COVID-19 Test]
    United States. Food and Drug Administration
    2020-07-24?
  • Fact Sheet for Healthcare Providers: Laboratory Corporation of America (LabCorp) COVID-19 RT-PCR Test
    United States. Food and Drug Administration
    2020-07-24
  • Fact Sheet for Healthcare Providers: Jiangsu CoWin Biotech Co., Ltd. Novel Coronavirus (SARS-CoV-2) Fast Nucleic Acid Detection Kit (PCR-Fluorescence Probing)
    United States. Food and Drug Administration
    2020-07-24
  • Fact Sheet for Healthcare Providers: Emergency Use of the Airway Dome
    United States. Food and Drug Administration
    2020-07-24
  • Fact Sheet for Healthcare Providers: DiaCarta, Inc. QuantiVirus™ SARS-CoV-2 Multiplex Test Kit
    United States. Food and Drug Administration
    2020-07-21
  • Fact Sheet for Healthcare Providers: Megna Health, Inc. - Rapid COVID-19 IgM/IgG Combo Test Kit
    United States. Food and Drug Administration
    2020-07-17
  • Fact Sheet for Healthcare Providers: Luminex Corporation, xMAP® SARS-CoV-2 Multi-Antigen IgG Assay
    United States. Food and Drug Administration
    2020-07-16
  • Fact Sheet for Healthcare Providers: Quest Diagnostics, Quest Diagnostics PF SARS-CoV-2 Assay
    United States. Food and Drug Administration
    2020-07-15
  • Fact Sheet for Healthcare Providers: Compass Laboratory Services SARS-CoV2 Assay - Compass Laboratory Services, LLC
    United States. Food and Drug Administration
    2020-07-13
  • Fact Sheet for Healthcare Providers: 'PhoenixDx SARS-CoV-2 Multiplex' - Trax Management Services Inc.
    United States. Food and Drug Administration
    2020-07-13
  • Fact Sheet for Healthcare Providers: Salofa Oy, Sienna-Clarity COVIBLOCK COVID-19 IgG/IgM Rapid Test Cassette
    United States. Food and Drug Administration
    2020-07-13
  • Fact Sheet for Healthcare Providers: PowerChek 2019-nCoV Real-time PCR Kit - KogeneBiotech Co., Ltd.
    United States. Food and Drug Administration
    2020-07-13
  • Fact Sheet for Healthcare Providers: Emergency Use of GammaCore Sapphire CV During the COVID-19 Pandemic
    United States. Food and Drug Administration
    2020-07-10
  • Fact Sheet for Healthcare Providers: Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. WANTAI SARS-CoV-2 Ab Rapid Test
    United States. Food and Drug Administration
    2020-07-10
  • Fact Sheet for Healthcare Providers: Real-Q 2019-nCoV Detection Kit- BioSewoom, Inc.
    United States. Food and Drug Administration
    2020-07-09
  • Fact Sheet for Healthcare Providers: Diazyme Laboratories, Inc. Diazyme DZ-Lite SARS-CoV-2 IgG CLIA Kit
    United States. Food and Drug Administration
    2020-07-08
  • Fact Sheet for Healthcare Providers: CareStart™ COVID-19 MDx RT-PCR - Access Bio, Inc.
    United States. Food and Drug Administration
    2020-07-07
  • Fact Sheet for Healthcare Providers: AMPIPROBE SARS-CoV-2 Test System, Enzo Life Sciences, Inc.
    United States. Food and Drug Administration
    2020-07-07
  • Fact Sheet for Healthcare Providers: Assure COVID-19 IgG/IgM Rapid Test Device - Assure Tech. (Hangzhou Co., Ltd)
    United States. Food and Drug Administration
    2020-07-06
  • Fact Sheet for Healthcare Providers: CDC Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay
    United States. Food and Drug Administration
    2020-07-02
  • Fact Sheet for Healthcare Providers: BD Veritor™ System for Rapid Detection of SARS-CoV-2 -- BD
    United States. Food and Drug Administration
    2020-07-02
  • Fact Sheet for Healthcare Providers: CentoFast-SARS-COV-2 RT-PCR Assay -- CENTOGENE US, LLC
    United States. Food and Drug Administration
    2020-07-01
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