FilmArray NGDS Warrior Panel— 510(k) K170883

Clearance details

Applicant

Biofire Defense, LLC

Product code

Code PRD

Advisory panel

Immunology

Date received

2017-03-24

Decision date

2017-06-22

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Salt Lake City, UT, US

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• Z-2877-2026 — 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 use with the FilmArray 2.0 system. The FilmArray NGDS Warrior Panel detects and identifies Bacillus anthracis, Yersinia pestis, Francisella tularensis, Coxiella burnetii, Ebola virus, and Marburg virus nucleic acids directly from human whole blood (EDTA).Class II·Ongoing·Biofire Defense·20260716
• Z-2609-2025 — 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.Class II·Ongoing·Biofire Defense·20250710
• Z-1448-2020 — FilmArray NGDS Warrior Panel, Ref: NGDS-ASY-0007, UDI: (01)00851458005136, IVD, Rx OnlyClass III·Terminated·Biofire Defense·20190820

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K170883.