BioFire COVID | 合法醫療器材資訊網
NowthefirstFDADeNovoauthorizedtestforCOVID-19,theBioFireRP2.1Paneldetects22respiratorypathogens,includingSARS-CoV-2,tohelpclinicians ...
SARS-CoV-2 Reactivity with BioFire Respiratory PanelsBioinformatics for the SARS-CoV-2 virus is expanding at a rapid rate since the emergence of the virus in human infection in late 2019. Thousands of viral whole genome sequences are being evaluated and submitted to public and private databases on a weekly basis.
BioFire continues to monitor these new sequences and is performing regular in silico analyses of the SARS-CoV-2 assays in the BioFire RP2.1 Panel family of products (the BioFire RP2.1 Panel, the BioFire® Respiratory 2.1 plus Panel**, and the BioFire RP2.1-EZ Panel [EUA]) in accordance with the FDA’s policy for evaluating the impact of viral mutations on COVID-19 tests.
Please consult the BioFire Respiratory Panels SARS-CoV-2 Reactivity Technical Note[1] for the latest reactivity updates with emerging variants.
References SARS-CoV-2 ...BioFire COVID | 合法醫療器材資訊網
BIOFIRE® Respiratory 2.1 plus Panel | 合法醫療器材資訊網
Company Name Company Address FilmArray Respiratory ... | 合法醫療器材資訊網
Evaluation of the BioFire FilmArray® Respiratory ... | 合法醫療器材資訊網
FilmArray Respiratory Panel EZ | 合法醫療器材資訊網
FilmArray® Panels—Infectious Disease Diagnostics | 合法醫療器材資訊網
Multicenter Evaluation of BioFire FilmArray ... | 合法醫療器材資訊網
Multicenter Evaluation of BioFire FilmArray ... | 合法醫療器材資訊網
Respiratory Pathogen Panel Test | 合法醫療器材資訊網
TECHNICAL : | 合法醫療器材資訊網
【微晶呼吸道病原體多標的核酸檢測第二代試劑組】許可證字號:衛部醫器輸字第032035號
器材品名:微晶呼吸道病原體多標的核酸檢測第二代試劑組許可證字號:衛部醫器輸字第032035號註銷狀態:註銷日期:註銷理由:有效...