The following data is part of a De Novo classification by Diagnostic Hybrids, Inc. with the FDA for Quidel Molecular Direct Hsv 1 +2/vzv Assay.
| DeNovo ID | DEN140004 |
| Device Name: | QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY |
| Classification | Herpes Virus (vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples |
| Applicant | DIAGNOSTIC HYBRIDS, INC. 2005 E State St Ste 100 Athens, OH 45701 |
| Contact | Ronald H Lollar |
| Product Code | PGI |
| CFR Regulation Number | 866.3309 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | K133448 |
| Review Advisory Board | Microbiology |
| Classification Advisory | Microbiology |
| Type | Post-NSE |
| Date Received | 2014-02-21 |
| Decision Date | 2014-05-13 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30014613311027 | DEN140004 | 000 |