The following data is part of a De Novo classification by Gen-probe Incorporated with the FDA for Aptima Trichomonas Vaginalis Assay.
| DeNovo ID | DEN110012 |
| Device Name: | APTIMA TRICHOMONAS VAGINALIS ASSAY |
| Classification | Trichomonas Vaginalis Nucleic Acid Amplification Test System |
| Applicant | GEN-PROBE INCORPORATED 10210 Genetic Center Drive San Diego, CA 92121 |
| Contact | Maria Carmelita S Baluyot |
| Product Code | OUY |
| CFR Regulation Number | 866.3860 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | K102911 |
| Review Advisory Board | Microbiology |
| Classification Advisory | Immunology |
| Type | Post-NSE |
| Date Received | 2011-04-13 |
| Decision Date | 2011-04-19 |
| FDA Review | Decision Summary |
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