Panels › Microbiology › Product code QSN · Class 2
Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System
Regulation 866.3988
0510(k)s in 12 months (1 all time)
2recalls in 12 months (2 all time)
0recalls that name a 510(k)
Top companies in QSN
| Company | 510(k)s | Recalls |
|---|---|---|
| Biofire Diagnostics, LLC | 1 | 2 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 13, 2026 | BioFire Diagnostics, LLC Generic Name: BioFire Joint Infection (JI) Panel
Generic Name: BioFire Joint Infection (JI) Panel
Model/Catalog Number: RFIT-ASY-0138 (30 Kit), RFIT-ASY-0135 (6 Kit)
Software Version: N/A
Product Desc Open, Classified |
QSN | None listed |
| May 6, 2026 | BioFire Diagnostics, LLC BioFire Joint Infection (JI) Panel
REF: RFIT-ASY-0138, 30 test Kit. Open, Classified |
QSN | None listed |
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