510(k) K181493 ยท PEN Gram-Negative Bacteria And Associated Resistance Markers
FilmArray Blood Culture Identification (BCID) Panel
| Applicant | Biofire Diagnostics, LLC, Salt Lake City UT, US |
| Decision | Substantially Equivalent, Jul 5, 2018 |
| Received | Jun 6, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K181493
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2021 | BioFire Diagnostics, LLC FilmArray Blood Culture Identification (BCID) Panel
Product Pouch Label:
FilmArray BCID Panel
Part No: RFIT-ASY-0126
Part No: RFIT-ASY-0127 Terminated |
PEN | None listed |
| Jan 26, 2021 | BioFire Diagnostics, LLC Gram-Negative Bacteria And Associated Resistance Markers;
Film Array Blood Culture Identification (BCID); Film Array BCID Panel - Product Usage: intended for use with FilmArray systems.
Part No: RFIT- Terminated |
PEN | None listed |
| Jan 22, 2020 | BioFire Diagnostics, LLC FilmArray BCID Panel, RFIT-ASY-0126, 30, Rx Only, CE, IVD, UDI: 00815381020086 used with the following BACT/ALERT Blood Culture Bottle Catalog No./Description:
410851/BACT/ALERT FA Plus
410852/BA Terminated |
PEN | None listed |
| Jan 22, 2020 | BioFire Diagnostics, LLC FilmArray BCID Panel, RFIT-ASY-0127, 6, Rx Only, CE, IVD, UDI: 00815381020093 used with the following BACT/ALERT Blood Culture Bottle Catalog No./Description:
410851/BACT/ALERT FA Plus
410852/BAC Terminated |
PEN | None listed |
| Mar 7, 2019 | BioFire Diagnostics, LLC FilmArray BCID Panel, IVD, Rx Only, BioFire Diagnostics,
REF: RFIT-ASY-0126, and RFIT-ASY-0127,
when used with the following blood culture bottles: Bottle Description/Part Number: BACT/ALERT FA Plus/4 Terminated |
PEN | None listed |
| Oct 30, 2018 | BioFire Diagnostics, LLC FilmArray Blood Culture Identification (BCID), IVD, Rx Only, BioFire Diagnostics, LLC, Panel Catalog Numbers/ UDI:
RFIT-ASY-0126 (30 test kit)/ 00815381020086,
RFIT-ASY-0127 (6 test kit)/ 00815381020 Terminated |
PAM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.