The following data is part of a De Novo classification by Cepheid with the FDA for Xpert Mtb/rif Assay.
| DeNovo ID | DEN130032 |
| Device Name: | XPERT MTB/RIF ASSAY |
| Classification | System, Nucleic Acid-based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen |
| Applicant | CEPHEID 904 Caribbean Drive Sunnyvale, CA 94089 |
| Contact | Kerry J Flom |
| Product Code | PEU |
| CFR Regulation Number | 866.3373 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | K131706 |
| Review Advisory Board | Microbiology |
| Classification Advisory | Microbiology |
| Type | Direct |
| Date Received | 2013-06-11 |
| Decision Date | 2013-07-25 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332940000912 | DEN130032 | 000 |