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  • Fact Sheet for Healthcare Providers: Quadrant Biosciences Inc., Clarifi COVID-19 Test Kit
    United States. Food and Drug Administration
    2020-09-22
  • Fact Sheet for Healthcare Providers: Kimforest Enterprise Co., Ltd, KimForest SARS-CoV-2 Detection Kit v1
    United States. Food and Drug Administration
    2020-09-21
  • Fact Sheet for Healthcare Providers: GK Pharmaceuticals Contract Manufacturing Operations, GK ACCU-RIGHT SARS-CoV-2 RT-PCR KIT
    United States. Food and Drug Administration
    2020-09-18
  • Fact Sheet for Healthcare Providers: Visby Medical, Inc., Visby Medical COVID-19
    United States. Food and Drug Administration
    2020-09-16
  • Fact Sheet for Healthcare Providers: Shenzhen New Industries Biomedical Engineering Co., Ltd. (SNIBE), MAGLUMI 2019-nCoV IgM/IgG
    United States. Food and Drug Administration
    2020-09-14
  • Fact Sheet for Healthcare Providers: Roche Molecular Systems, Inc., cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test for use on the cobas Liat System
    United States. Food and Drug Administration
    2020-09-14
  • Fact Sheet for Healthcare Providers: BioCheck Inc., BioCheck SARS-CoV-2 IgM Antibody Test Kit
    United States. Food and Drug Administration
    2020-09-09
  • Fact Sheet for Healthcare Providers:Beijing Wantai Biological Pharmacy Enterprise Co., Ltd., Wantai SARS-CoV-2 RT-PCR Kit
    United States. Food and Drug Administration
    2020-09-09
  • 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: BillionToOne, Inc., qSanger-COVID-19 Assay
    United States. Food and Drug Administration
    2020-09-04
  • 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: Roche Molecular Systems, Inc., cobas SARS-CoV-2 & Influenza A/B
    United States. Food and Drug Administration
    2020-09-03
  • Fact Sheet for Healthcare Providers: Bioeksen R&D Technologies Ltd., Bio-Speedy Direct RT-qPCR SARS-CoV-2
    United States. Food and Drug Administration
    2020-09-02
  • 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: BayCare Laboratories, LLC, BayCare SARS-CoV-2 RT PCR Assay
    United States. Food and Drug Administration
    2020-08-31
  • Fact Sheet for Healthcare Providers: TBG Biotechnology Corp., TBG SARS-CoV-2 IgG/IgM Rapid Test Kit
    United States. Food and Drug Administration
    2020-08-31
  • Fact Sheet for Healthcare Providers: University of Arizona Genetics Core for Clinical Services, COVID-19 ELISA pan-Ig Antibody Test
    United States. Food and Drug Administration
    2020-08-31
  • Fact Sheet for Healthcare Providers: T2 Biosystems, Inc., T2SARS-CoV-2 Panel
    United States. Food and Drug Administration
    2020-08-31
  • Fact Sheet for Healthcare Providers: Mammoth Biosciences, Inc., SARS-CoV-2 DETECTR Reagent Kit
    United States. Food and Drug Administration
    2020-08-31
  • 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: Abbott Diagnostics Scarborough, Inc. BinaxNOW™ COVID-19 Ag Card
    United States. Food and Drug Administration
    2020-08-26
  • 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: Fluidigm Corporation Advanta Dx SARS-CoV-2 RT-PCR Assay
    United States. Food and Drug Administration
    2020-08-25
  • 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 Providers: DxTerity SARS-CoV-2 RT-PCR Test
    United States. Food and Drug Administration
    2020-08-21
  • 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: 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
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