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  • 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
  • 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: Poplar SARS-CoV-2 TMA Pooling Assay, Poplar Healthcare
    United States. Food and Drug Administration
    2020-08-03
  • Fact Sheet for Healthcare Providers: Ethos Laboratories -- Ethos Laboratories SARS-CoV-2 MALDI-TOF Assay
    United States. Food and Drug Administration
    2020-08-03
  • Fact Sheet for Healthcare Providers: Emergency Use of Impella Left Ventricular Support Systems During the COVID-19 Outbreak
    United States. Food and Drug Administration
    2020-08-03
  • Fact Sheet for Healthcare Providers: Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Tests [Cleveland Clinic SARS-CoV-2 Assay]
    United States. Food and Drug Administration
  • Fact Sheet for Healthcare Providers: Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Tests [Wren Laboratories COVID-19 PCR Test]
    United States. Food and Drug Administration
  • Letter of Authorization: UCSD RC SARS-CoV-2 Assay
    United States. Food and Drug Administration
    Hinton, Denise M.
    2020-07-31
  • Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised)
    United States. Food and Drug Administration
    2020-04
  • 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: DiaCarta, Inc. QuantiVirus™ SARS-CoV-2 Multiplex Test Kit
    United States. Food and Drug Administration
    2020-07-21
  • Fact Sheet for Healthcare Providers: Emergency Use of the Negative-Pressure Respiratory System with Advanced Ventilation Return (NRSAVR-100)
    United States. Food and Drug Administration
    2020-06-13
  • Fact Sheet for Healthcare Providers: Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit, Biohit Healthcare (Hefei) Co. Ltd.
    United States. Food and Drug Administration
    2020-06-18
  • Fact Sheet for Healthcare Providers: LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold), Hangzhou Laihe Biotech Co., Ltd
    United States. Food and Drug Administration
    2020-06-19
  • Fact Sheet for Healthcare Providers: Emory Medical Laboratories SARS-CoV-2 RBD IgG Test
    United States. Food and Drug Administration
    2020-06-15
  • Fact Sheet for Healthcare Providers: TRUPCR SARS-CoV-2 Kit, 3B Blackbio Biotech India Ltd, A Subsidiary of Kilpest India Ltd.
    United States. Food and Drug Administration
    2020-06-18
  • Fact Sheet for Healthcare Providers: COVID-19 Coronavirus Real Time PCR Kit -- Jiangsu Bioperfectus Technologies Co., Ltd.
    United States. Food and Drug Administration
    2020-06-18
  • Fact Sheet for Healthcare Providers: KPMAS COVID-19 Test - Kaiser Permanente Mid-Atlantic States
    United States. Food and Drug Administration
    2020-06-13
  • Fact Sheet for Healthcare Providers: BioCode SARS-CoV-2 Assay - Applied BioCode, Inc.
    United States. Food and Drug Administration
    2020-06-15
  • 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: Compass Laboratory Services SARS-CoV2 Assay - Compass Laboratory Services, LLC
    United States. Food and Drug Administration
    2020-07-13
  • 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: Quest Diagnostics, Quest Diagnostics PF SARS-CoV-2 Assay
    United States. Food and Drug Administration
    2020-07-15
  • 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: CareStart™ COVID-19 MDx RT-PCR - Access Bio, Inc.
    United States. Food and Drug Administration
    2020-07-07
  • 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: AMPIPROBE SARS-CoV-2 Test System, Enzo Life Sciences, Inc.
    United States. Food and Drug Administration
    2020-07-07
  • 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: Interpreting Gene-RADAR Zika Virus Test Results
    United States. Food and Drug Administration
    2017-03-23
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