Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System
Regulation 866.4001
0510(k)s in 12 months (3 all time)
1recalls in 12 months (6 all time)
4recalls that name a 510(k)
Top companies in QDS
| Company | 510(k)s | Recalls |
|---|---|---|
| Biofire Diagnostics, LLC | 2 | 6 |
| Biofire Diagnostics, LLC (Biomerieux) | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 13, 2026 | BioFire Diagnostics, LLC Generic Name: FilmArray Pneumonia Panel plus
Generic Name: FilmArray Pneumonia Panel plus
Model/Catalog Number: RFIT-ASY-0143 (30 Kit), RFIT-ASY-0142 (6 Kit)
Software Version: N/A
Product Description: Open, Classified |
QDS | K243222 |
| Apr 4, 2025 | BioFire Diagnostics, LLC FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374 Open, Classified |
QDS | K181324 K222601 +1 |
| Aug 16, 2024 | BioFire Diagnostics, LLC BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143 Open, Classified |
QDS | None listed |
| Aug 16, 2024 | BioFire Diagnostics, LLC BIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144 Open, Classified |
QDS | None listed |
| Feb 6, 2024 | BioFire Diagnostics, LLC FilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IVD, Rx Only (30 test kit) Open, Classified |
QDS | K181324 |
| Jun 7, 2021 | BioFire Diagnostics, LLC FilmArray Pneumonia Panel plus (Pneumoplus)
Part Numbers:
Part No: RFIT-ASY-0143 / UDI: 00815381020314 (30 test kit)
Part No: RFIT-ASY-0142 / UDI: 00815381020321 (6 test kit) Terminated |
QDS | K181324 |
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