The following data is part of a De Novo classification by Cepheid with the FDA for Xpert Ev, Model Gxev-100n-10; Genexpert Dx System, Models P/n 900-0144, 900-0145, 900-0146, 900-0065.
| DeNovo ID | DEN070004 |
| Device Name: | XPERT EV, MODEL GXEV-100N-10; GENEXPERT DX SYSTEM, MODELS P/N 900-0144, 900-0145, 900-0146, 900-0065 |
| Classification | Assay, Enterovirus Nucleic Acid |
| Applicant | CEPHEID 904 Caribbean Drive Sunnyvale, CA 94089 -1189 |
| Contact | Russel K Enns, Ph.d. |
| Product Code | OAI |
| CFR Regulation Number | 866.3225 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | K061062 |
| Review Advisory Board | Microbiology |
| Classification Advisory | Microbiology |
| Type | Post-NSE |
| Date Received | 2007-03-12 |
| Decision Date | 2007-03-16 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332940000097 | DEN070004 | 000 |