US FDA – BioFire COVID | 合法醫療器材資訊網
TheBioFire®COVID-19TestisanestedmultiplexedRT-PCRtestintendedforthe ...
US FDA – BioFire COVID-19 Test v1.1This product has not been FDA cleared or approved but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories;
This product has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and
The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug,...
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US FDA – BioFire COVID | 合法醫療器材資訊網
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