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  • Fact Sheet for Healthcare Providers: Emergency Use of the Patient Isolation Transport Unit (PITU)
    United States. Food and Drug Administration
    2020-05-08
  • Fact Sheet for Healthcare Providers: DIAGNOVITAL SARS-CoV-2 Real-Time PCR Kit- RTA Laboratories Biological Products Pharmaceutical and Machinery Industry
    United States. Food and Drug Administration
    2020-06-12
  • Fact Sheet for Healthcare Providers: New York SARS-CoV-2 Real-Time RT-PCR Diagnostic Panel
    United States. Food and Drug Administration
    2020-03-15
  • Fact Sheet for Healthcare Providers: Emergency Use of a Protective Barrier Enclosure During the COVID-19 Pandemic
    United States. Food and Drug Administration
    2020-05-01
  • Fact Sheet for Healthcare Providers: Emergency Use of the B. Braun Space and Outlook Pumps During the COVID-19 Pandemic
    United States. Food and Drug Administration
    2020-04-11
  • Fact Sheet for Healthcare Providers: Babson Diagnostics aC19G1, Babson Diagnostics, Inc.
    United States. Food and Drug Administration
    2020-06-23
  • Fact Sheet for Healthcare Providers: LifeHope 2019-nCoV Real-Time RT-PCR Diagnostic Panel
    United States. Food and Drug Administration
  • Fact Sheet for Healthcare Providers: Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Tests [Acupath COVID-19 Real-Time (RT-PCR) Assay]
    United States. Food and Drug Administration
    2020?
  • Fact Sheet for Healthcare Providers: Fastplex Triplex SARS-CoV-2 Detection Kit (RT-Digital PC), PreciGenome LLC
    United States. Food and Drug Administration
    2020-06-25
  • Fact Sheet for Healthcare Providers: COVID-19 RT-PCR Peptide Nucleic Acid (PNA) Kit, TNS Co., Ltd (Bio TNS)
    United States. Food and Drug Administration
    2020-06-30
  • Fact Sheet for Healthcare Providers: IntelliPlex SARS-CoV-2 Detection Kit - PlexBio Co., Ltd.
    United States. Food and Drug Administration
    2020-06-25
  • Fact Sheet for Healthcare Providers: GenePro SARS-CoV-2 Test - Gencurix, Inc.
    United States. Food and Drug Administration
    2020-06-23
  • 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: 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: InBios International, Inc. -- SCoV-2 'Detect'™ IgM ELISA
    United States. Food and Drug Administration
    2020-06-30
  • 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 Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Tests [CRSP SARS-CoV-2 Real-Time Reverse Transcriptase (RT) PCR Diagnostic Assay]
    United States. Food and Drug Administration
    2020?
  • Fact Sheet for Healthcare Providers: Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Tests [BMC-CReM COVID-19 Test]
    United States. Food and Drug Administration
    2020?
  • Fact Sheet for Healthcare Providers: Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Tests [Gene By Gene SARS-CoV-2 Detection Test]
    United States. Food and Drug Administration
    2020?
  • 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: 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: Luminex Corporation, xMAP® SARS-CoV-2 Multi-Antigen IgG Assay
    United States. Food and Drug Administration
    2020-07-16
  • 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: 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: 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: 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: 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 the Airway Dome
    United States. Food and Drug Administration
    2020-07-24
  • 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?
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