SIMPLEXA HSV 1&2 DIRECT
Hsv-1 And Hsv-2 Cns Nucleic-acid Based Panel
FOCUS DIAGNOSTICS
The following data is part of a De Novo classification by Focus Diagnostics with the FDA for Simplexa Hsv 1&2 Direct.
Pre-market Notification Details
| DeNovo ID | DEN130049 |
| Device Name: | SIMPLEXA HSV 1&2 DIRECT |
| Classification | Hsv-1 And Hsv-2 Cns Nucleic-acid Based Panel |
| Applicant | FOCUS DIAGNOSTICS 11331 Valley View Street Cypress, CA 90630 |
| Contact | Sharon Young |
| Product Code | PGH |
| CFR Regulation Number | 866.3307 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | K133621 |
| Review Advisory Board | Microbiology |
| Classification Advisory | Microbiology |
| Type | Direct |
| Date Received | 2013-11-25 |
| Decision Date | 2014-03-21 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |
NIH GUDID Devices
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