The following data is part of a De Novo classification by Curetis Gmbh with the FDA for Curetis Unyvero Lrt Application.
| DeNovo ID | DEN170047 |
| Device Name: | Curetis Unyvero LRT Application |
| Classification | Lower Respiratory Microbial Nucleic Acid Detection System |
| Applicant | Curetis GmbH max-eyth Strabe 42 Holzgerlingen, DE 71088 |
| Contact | Gail E. Radcliffe |
| Product Code | QBH |
| CFR Regulation Number | 866.3985 [🔎] |
| 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 | 2017-09-11 |
| Decision Date | 2018-04-03 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260364750041 | DEN170047 | 000 |
| 04260364750034 | DEN170047 | 000 |