510(k) K193519 ยท PEN Gram-Negative Bacteria And Associated Resistance Markers
BioFire Blood Culture Identification 2 (BCID2) Panel
| Applicant | Biofire Diagnostics, LLC, Salt Lake City UT, US |
| Decision | Substantially Equivalent, Mar 18, 2020 |
| Received | Dec 19, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193519
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 31, 2024 | BioFire Diagnostics, LLC BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, for FILMARRAY Systems, when used in conjunction with Culture Media Bottles: BACT/ALERT FA PLUS, REF: 410851, and BACT/ALERT PF Open, Classified |
PEN | None listed |
| Feb 15, 2024 | BioFire Diagnostics, LLC BIOFIRE Blood Culture Identification 2 (BCID2) Panel
when used with:
BD BACTEC Lytic Anaerobic medium
BD BACTEC Peds Plus medium
BD BACTEC Plus Aerobic medium
BD BACTEC Plus Anaerobic medium
BD BACTE Open, Classified |
PEN | None listed |
| Dec 1, 2023 | BioFire Diagnostics, LLC BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, used with Maine Molecular Quality Controls, Inc (MMQCI) FilmArray BCID2 Control Panel M416, which is referenced in Quality Con Open, Classified |
PEN | None listed |
| Mar 15, 2023 | BioFire Diagnostics, LLC In Vitro Diagnostic (IVD) Panel
BioFire BCID2 Panel - REF RFIT-ASY-0147 Open, Classified |
PEN | None listed |
| Oct 11, 2021 | BioFire Diagnostics, LLC BioFire Blood Culture Identification 2 (BCID2) Panel
Part No: RFIT-ASY-0147
UDI: 00815381020338
Blood Culture Catalog No./Description:
442023/BD BACTEC Plus Aerobic medium in plastic vials
442021/BD Terminated |
PEN | None listed |
| May 10, 2021 | BioFire Diagnostics, LLC BioFire BCID2 Panel, REF RFIT-ASY-0147, For FilmArray Systems, CE, Blood Culture Identification Panel in vitro diagnostic, Rx Only, UDI: (01)00815381020338 Terminated |
PEN | None listed |
| Jan 26, 2021 | BioFire Diagnostics, LLC BioFire BCID2 Panel; IVD, Rx Only Part No: RFIT-ASY-0147 / UDI: 00815381020338 - Product Usage: intended for use with FilmArray systems. Terminated |
PEN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.