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  • 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: Yale School of Public Health, Department of Epidemiology of Microbial Diseases; SalivaDirect
    United States. Food and Drug Administration
    2020-08-15
  • Fact Sheet for Healthcare Providers: LumiraDx UK Ltd., LumiraDx SARS-CoV-2 RNA STAR
    United States. Food and Drug Administration
    2020-08-11
  • Fact Sheet for Healthcare Providers: Biomeme, Inc.; Biomeme SARS-CoV-2 Real-Time RT-PCR Test
    United States. Food and Drug Administration
    2020-08-11
  • Fact Sheet for Healthcare Providers: Emergency Use of the Prismaflex HF20 Set During the COVID-19 Pandemic
    United States. Food and Drug Administration
    2020-08-10
  • Fact Sheet for Healthcare Providers: bioMerieux, Inc.; VIDAS® SARS-COV-2 IgG
    United States. Food and Drug Administration
    2020-08-06
  • Fact Sheet for Healthcare Providers: bioMérieux, Inc.; VIDAS® SARS-COV-2 IgM
    United States. Food and Drug Administration
    2020-08-06
  • Fact Sheet for Healthcare Providers: Vela Operations Singapore Pte Ltd.; ViroKey™ SARS-CoV-2 RT-PCR Test
    United States. Food and Drug Administration
    2020-08-05
  • Fact Sheet for Healthcare Providers: Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.; WANTAI SARS-CoV-2 Ab ELISA
    United States. Food and Drug Administration
    2020-08-05
  • 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: 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
  • 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
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