Product code PRD
PRD
0510(k)s in 12 months (3 all time)
1recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in PRD
| Company | 510(k)s | Recalls |
|---|---|---|
| Biofire Defense, LLC | 3 | 3 |
| 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 | K170883 |
| 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 | K170883 |
| Feb 18, 2020 | Biofire Defense FilmArray NGDS Warrior Panel, Ref: NGDS-ASY-0007, UDI: (01)00851458005136, IVD, Rx Only Terminated |
PRD | K170883 |
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