Biofire Diagnostics, LLC
FDA 510(k) medical device clearances.
Top product codes for Biofire Diagnostics, LLC
Recent clearances by Biofire Diagnostics, LLC
- K243544 — BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini
- K243885 — BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid
- K243759 — BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack))
- K242367 — BIOFIRE FILMARRAY Gastrointestinal (GI) Panel
- K241194 — BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini
- K232954 — BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel
- K230719 — BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini
- K230404 — BIOFIRE FILMARRAY Gastrointestinal (GI) Panel
- K222601 — FilmArray Pneumonia Panel plus
- DEN200066 — BioFire Joint Infection (JI) Panel
- K212727 — FilmArray Pneumonia Panel
- DEN200031 — BioFire Respiratory Panel 2.1 (RP2.1)
- K193519 — BioFire Blood Culture Identification 2 (BCID2) Panel
- K181324 — FilmArray Pneumonia Panel plus
- K180966 — FilmArray Pneumonia Panel
- K181493 — FilmArray Blood Culture Identification (BCID) Panel
- DEN170017 — FilmArray Respiratory Panel 2 plus (RP2plus)
- K170604 — FilmArray Respiratory Panel 2 (RP2)
- K152579 — FilmArray Respiratory Panel EZ (RP EZ)
- K160459 — FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch
- K160462 — FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch
- K160457 — FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch
- K160068 — FilmArray Respiratory Panel (RP) for use with FilmArray Torch
- DEN150013 — FilmArray Meningitis/Encephalitis(ME) Panel
- K143005 — FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0
- K143080 — FilmArray Respiratory Panel (RP) for use with Multi-instrument FilmArray System
- K143171 — FilmArray Blood Culture Identification (BCID) Panel for use with the FilmArray 2.0
- K143178 — FilmArray 2.0 System
Data sourced from openFDA. This site is unofficial and independent of the FDA.