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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 6 of 6 Results
510(K) Number: K193519
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BIOFIRE Blood Culture Identification 2 (BCID2) Panel when used with: BD BACTEC Lytic Anaerobic m... 2 02/15/2024 BioFire Diagnostics, LLC
BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, used with Maine Molecular ... 2 12/01/2023 BioFire Diagnostics, LLC
In Vitro Diagnostic (IVD) Panel BioFire BCID2 Panel - REF RFIT-ASY-0147 2 03/15/2023 BioFire Diagnostics, LLC
BioFire Blood Culture Identification 2 (BCID2) Panel Part No: RFIT-ASY-0147 UDI: 00815381020338 Blo... 2 11/30/2021 BioFire Diagnostics, LLC
BioFire BCID2 Panel, REF RFIT-ASY-0147, For FilmArray Systems, CE, Blood Culture Identification Pane... 2 06/21/2021 BioFire Diagnostics, LLC
BioFire BCID2 Panel; IVD, Rx Only Part No: RFIT-ASY-0147 / UDI: 00815381020338 - Product Usage: inte... 2 03/01/2021 BioFire Diagnostics, LLC
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