WebThe COVID-19 Antigen Rapid Test Device is for professional in vitro diagnostic use, and should only be used for the qualitative detection of SARS-CoV-2 antigen. The intensity not be evaluated as “quantitative or semi-quantitative”. 2. Both viable and nonviable SARS -CoV 2 viruses are detectable with The COVID 19 Antigen Rapid Test Device. WebNov 5, 2024 · GREENSBORO, N.C., Nov. 5, 2024 /PRNewswire/ -- The Fastep® COVID-19 IgG/IgM Rapid Test Device by Assure Tech., distributed in the USA by Carolina Liquid Chemistries, has received FDA …
In Vitro Diagnostics EUAs - Antigen Diagnostic Tests for SARS …
WebSep 30, 2024 · The issuance of the EUA for the first point-of-care antibody test for COVID-19 in the U.S. using fingerstick blood samples is an important advancement, which we … WebSep 30, 2024 · The issuance of the EUA for the first point-of-care antibody test for COVID-19 in the U.S. using fingerstick blood samples is an important advancement, which we believe will lead to significant demand for the FaStep COVID-19 IgG/IgM Rapid Test Device as a fast, convenient and reliable method for COVID-19 serology testing." trick with card
Class 2 Device Recall FaStep COVID19 IgG/IgM Rapid Test Device
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