The following data is part of a De Novo classification by Geneohm Sciences Canada , Inc (bd Diagnostics) with the FDA for Bd Max Vaginal Panel, Bd Max Instrument.
| DeNovo ID | DEN160001 |
| Device Name: | BD MAX Vaginal Panel, BD MAX Instrument |
| Classification | Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System |
| Applicant | GENEOHM SCIENCES CANADA , INC (BD DIAGNOSTICS) 2555 Boul. De Parc-technologique Quebec, CA Gip 4s5 |
| Contact | Manon Richard |
| Product Code | PQA |
| CFR Regulation Number | 866.3975 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | Microbiology |
| Classification Advisory | Microbiology |
| Type | Direct |
| Date Received | 2016-01-11 |
| Decision Date | 2016-10-28 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382904437121 | DEN160001 | 000 |