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  1. www.fda.gov › medical-devices › products-and-medical-proceduresIn Vitro Diagnostics | FDA - U.S. Food and Drug Administration

    23 de feb. de 2023 · In vitro diagnostics (IVD) are tests done on samples such as blood or tissue that have been taken from the human body. In vitro diagnostics can detect diseases or other conditions, and can be...

  2. www.fda.gov › regulatory-information › search-fda-guidance-documentsEstablishing the Performance Characteristics of In Vitro...

    15 de jul. de 2011 · FDA is issuing this guidance to provide industry and agency staff with recommendations for studies to establish the analytical and clinical performance of in vitro diagnostic devices (IVDs ...

  3. www.fda.gov › medical-devices › tests-used-clinical-careFind All FDA-Approved Home and Lab Tests | FDA

    You can find information about each home or lab test that FDA has approved or cleared by searching FDA’s Database of In Vitro Diagnostic (IVD) Tests.

  4. www.fda.gov › medical-devices › guidance-documents-medical-devices-and-radiationTesting for Detection and Differentiation of Influenza A Virus...

    9 de oct. de 2009 · Multiplex nucleic acid assays testing for detection and differentiation of Influenza A virus subtypes are intended to detect influenza A RNA and specific Influenza A subtype RNA extracted from ...

  5. wwwnc.cdc.gov › eid › articleVolume 27, Number 7—July 2021 - Centers for Disease Control and...

    13 de may. de 2021 · The simultaneous detection and differentiation of these 3 major pathogens increases overall testing capacity, conserves resources, identifies co-infections, and enables efficient surveillance of influenza viruses and SARS-CoV-2.

  6. www.nature.com › articles › s41579/020/00461-zConsiderations for diagnostic COVID-19 tests - Nature

    14 de oct. de 2020 · 496 Citations. 106 Altmetric. Metrics. Abstract. During the early phase of the coronavirus disease 2019 (COVID-19) pandemic, design, development, validation, verification and implementation of...

  7. www.accessdata.fda.gov › cdrh_docs › pdf20March 10, 2020 - Food and Drug Administration

    The Influenza A/H5 Subtyping Kit contains reagents and controls of the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel and is intended for use in real-time RT-PCR (rRT-PCR) assays...