510(k) K170883 ยท PRD
FilmArray NGDS Warrior Panel
| Applicant | Biofire Defense, LLC, Salt Lake City UT, US |
| Decision | Substantially Equivalent, Jun 22, 2017 |
| Received | Mar 24, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170883
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 4, 2026 | Biofire Defense FilmArray NGDS Warrior Panel REF NGDS-ASY-0007
UDI-DI code: (01)00851458005136
The FilmArray NGDS Warrior Panel is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test intended for Open, Classified |
PRD | None listed |
| Sep 19, 2025 | Biofire Defense FilmArray NGDS Warrior Panel NGDS-ASY-0007 is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test intended for use with the FilmArray 2.0 system. Open, Classified |
PRD | None listed |
| Feb 18, 2020 | Biofire Defense FilmArray NGDS Warrior Panel, Ref: NGDS-ASY-0007, UDI: (01)00851458005136, IVD, Rx Only Terminated |
PRD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.