| BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini (K243544) | Biofire Diagnostics, LLC | 2025-08-14 |
| BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid (K243885) | Biofire Diagnostics, LLC | 2025-01-16 |
| BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack)) (K243759) | Biofire Diagnostics, LLC | 2024-12-20 |
| BIOFIRE FILMARRAY Gastrointestinal (GI) Panel (K242367) | Biofire Diagnostics, LLC | 2024-11-07 |
| BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini (K241194) | Biofire Diagnostics, LLC | 2024-05-30 |
| BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel (K232954) | Biofire Diagnostics, LLC | 2024-03-26 |
| BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini (K230719) | Biofire Diagnostics, LLC | 2023-04-13 |
| BIOFIRE FILMARRAY Gastrointestinal (GI) Panel (K230404) | Biofire Diagnostics, LLC | 2023-03-16 |
| FilmArray Pneumonia Panel plus (K222601) | Biofire Diagnostics, LLC | 2022-10-27 |
| BioFire Joint Infection (JI) Panel (DEN200066) | Biofire Diagnostics, LLC | 2022-04-29 |
| FilmArray Pneumonia Panel (K212727) | Biofire Diagnostics, LLC | 2021-09-22 |
| BioFire Respiratory Panel 2.1 (RP2.1) (DEN200031) | Biofire Diagnostics, LLC | 2021-03-17 |
| BioFire Blood Culture Identification 2 (BCID2) Panel (K193519) | Biofire Diagnostics, LLC | 2020-03-18 |
| FilmArray Pneumonia Panel plus (K181324) | Biofire Diagnostics, LLC | 2018-11-15 |
| FilmArray Pneumonia Panel (K180966) | Biofire Diagnostics, LLC | 2018-11-09 |
| FilmArray Blood Culture Identification (BCID) Panel (K181493) | Biofire Diagnostics, LLC | 2018-07-05 |
| FilmArray Respiratory Panel 2 plus (RP2plus) (DEN170017) | Biofire Diagnostics, LLC | 2017-11-24 |
| FilmArray Respiratory Panel 2 (RP2) (K170604) | Biofire Diagnostics, LLC | 2017-05-30 |
| FilmArray Respiratory Panel EZ (RP EZ) (K152579) | Biofire Diagnostics, LLC | 2016-10-03 |
| FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch (K160459) | Biofire Diagnostics, LLC | 2016-04-01 |
| FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch (K160462) | Biofire Diagnostics, LLC | 2016-03-17 |
| FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch (K160457) | Biofire Diagnostics, LLC | 2016-03-15 |
| FilmArray Respiratory Panel (RP) for use with FilmArray Torch (K160068) | Biofire Diagnostics, LLC | 2016-02-08 |
| FilmArray Meningitis/Encephalitis(ME) Panel (DEN150013) | Biofire Diagnostics, LLC | 2015-10-08 |
| FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0 (K143005) | Biofire Diagnostics, LLC | 2015-02-19 |
| FilmArray Respiratory Panel (RP) for use with Multi-instrument FilmArray System (K143080) | Biofire Diagnostics, LLC | 2015-02-17 |
| FilmArray Blood Culture Identification (BCID) Panel for use with the FilmArray 2.0 (K143171) | Biofire Diagnostics, LLC | 2015-01-30 |
| FilmArray 2.0 System (K143178) | Biofire Diagnostics, LLC | 2015-01-30 |