510(k) K160459 ยท PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch
| Applicant | Biofire Diagnostics, LLC, Salt Lake City UT, US |
| Decision | Substantially Equivalent, Apr 1, 2016 |
| Received | Feb 19, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K160459
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 30, 2024 | BioFire Diagnostics, LLC FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-0116) Pouch Module Software Open, Classified |
PCH | None listed |
| Aug 6, 2024 | BioFire Diagnostics, LLC BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116
(30 test kit)
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0104
(6 kit test)
The BIOFIRE FILMARRAY Gastrointestinal (GI Open, Classified |
PCH | None listed |
| Feb 15, 2024 | BioFire Diagnostics, LLC FilmArray Gastrointestinal (GI) Panel
RFIT-ASY-0116 (30 test kit)
RFIT-ASY-0104 (6 test kit)
Gastrointestinal microorganism multiplex nucleic acid-based assay. In vitro diagnostic. Open, Classified |
PCH | None listed |
| Jan 10, 2024 | BioFire Diagnostics, LLC BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with BIOFIRE FILMARRAY Systems. Open, Classified |
PCH | None listed |
| Mar 15, 2023 | BioFire Diagnostics, LLC In Vitro Diagnostic (IVD) Panel
FilmArray GI Panel - REF RFIT-ASY-0116 Open, Classified |
PCH | None listed |
| Aug 8, 2019 | BioFire Diagnostics, LLC FilmArray Gastronintestinal (GI) Panel, REF: RFIT-ASY-0104, 6-pack kit, UDI (01)00815381020116, CE IVD, Rx Only Terminated |
PCH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.