Panels › Immunology › Product code OUY · Class 2
Trichomonas Vaginalis Nucleic Acid Amplification Test System
Regulation 866.3860
0510(k)s in 12 months (10 all time)
3recalls in 12 months (4 all time)
1recalls that name a 510(k)
Top companies in OUY
| Company | 510(k)s | Recalls |
|---|---|---|
| GET TESTED INTERNATIONAL AB | 0 | 3 |
| Becton, Dickinson & CO | 1 | 1 |
| Becton, Dickinson and Company | 2 | 0 |
| Cepheid | 2 | 0 |
| Gen-Probe Incorporated | 2 | 0 |
| Quidel Corporation | 2 | 0 |
| Hologic, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB 8 in 1 STI Test Kit Open, Classified |
OUY | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB 3 in 1 STI Test Open, Classified |
OUY | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB 2 in 1 Trichomonas / Gardnerella Test Open, Classified |
OUY | None listed |
| Jul 17, 2019 | Becton Dickinson & Co. Kit BD Max CT/GC/TV;
Catalog # 442970 Terminated |
OUY | K151589 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.