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  • Fact Sheet for Healthcare Providers: Nirmidas Biotech, Inc., Nirmidas COVID-19 (SARS-CoV-2) IgM/IgG Antibody Detection Kit
    United States. Food and Drug Administration
    2020-09-29
  • Fact Sheet for Healthcare Providers: NanoEntek America, Inc., FREND COVID-19 total Ab
    United States. Food and Drug Administration
    2020-09-29
  • Fact Sheet for Healthcare Providers: CENTOGENE US, LLC, CentoSure SARS-CoV-2 RT-PCR Assay
    United States. Food and Drug Administration
    2020-09-29
  • Fact Sheet for Healthcare Providers: DiaSorin Inc., LIAISON SARS-CoV-2 IgM
    United States. Food and Drug Administration
    2020-09-29
  • Fact Sheet for Healthcare Providers: Genetrack Biolabs, Inc., Genetrack SARS-CoV-2 Molecular Assay
    United States. Food and Drug Administration
    2020-09-25
  • Fact Sheet for Healthcare Providers: QUOTIENT SUISSE SA, MosaiQ COVID-19 Antibody Magazine
    United States. Food and Drug Administration
    2020-09-25
  • Fact Sheet for Healthcare Providers: Emergency Use of the COViage System During the COVID-19 Pandemic
    United States. Food and Drug Administration
    2020-09-24
  • Fact Sheet for Healthcare Providers: Emergency Use of the Duke University COVIAGE
    United States. Food and Drug Administration
    2020-09-24
  • Fact Sheet for Healthcare Providers: Clear Labs, Inc., Clear Dx SARS-CoV-2 Test
    United States. Food and Drug Administration
    2020-09-23
  • Updated Evidence to Support the Emergency Use of COVID-19 Convalescent Plasma - As of 9/23/2020
    United States. Food and Drug Administration
    2020-09-23
  • Fact Sheet for Healthcare Providers: JIANGSU WELL BIOTECH CO., LTD., Orawell IgM/IgG Rapid Test
    United States. Food and Drug Administration
    2020-09-23
  • Fact Sheet for Healthcare Providers: Azure Biotech Inc., Assure COVID-19 IgG/IgM Rapid Test Device
    United States. Food and Drug Administration
    2020-09-23
  • Fact Sheet for Healthcare Providers: Vela Operations Singapore Pte. Ltd., Virokey SARS-CoV-2 RT-PCR Test v2.0
    United States. Food and Drug Administration
    2020-09-22
  • 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
  • Investigational COVID-19 Convalescent Plasma: Guidance for Industry [September 2, 2020]
    United States. Food and Drug Administration; United States. Department of Health and Human Services; Center for Biologics Evaluation and Research (U.S.)
    2020-09-02
  • 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
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