Panels › Microbiology › Product code QEP · Class 2
Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections
Regulation 866.3393
3510(k)s in 12 months (24 all time)
0recalls in 12 months (4 all time)
3recalls that name a 510(k)
Top companies in QEP
| Company | 510(k)s | Recalls |
|---|---|---|
| Roche Molecular Systems, Inc. | 7 | 0 |
| Hologic, Inc. | 5 | 0 |
| Abbott Molecular, Inc. | 2 | 1 |
| Binx Health, Inc. | 2 | 1 |
| Visby Medical | 3 | 0 |
| Becton Dickinson & Co. | 0 | 2 |
| Bd Integrated Diagnostic Solutions/Becton, | 1 | 0 |
| Becton, Dickinson and Company | 1 | 0 |
| Cepheid | 1 | 0 |
| Neumodx Molecular, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 3, 2024 | Becton Dickinson & Co. BD COR GX Instrument
Version or Model: 443990
Catalog Number: 443990 Open, Classified |
QEP | None listed |
| Dec 3, 2024 | Becton Dickinson & Co. BD COR MX Instrument
Version or Model: 443989
Catalog Number: 443989 Open, Classified |
QEP | K210585 |
| Oct 29, 2024 | Abbott Molecular, Inc. Abbott Alinity m STI AMP Kit, used with the Alinity m System, product codes: a) REF 09N17-095; b) REF 09N17-090; c) REF 09N17-091; Open, Classified |
QEP | K222379 |
| May 23, 2023 | Binx Health, Inc. binx io CT/NG Assay- Single-use Cartridge for the qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae
Ref: 1.002.101 Open, Classified |
QEP | K200533 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.