The following data is part of a De Novo classification by Centers For Disease Control And Prevention with the FDA for Cdc Denv-1-4 Real Time Rt-pct Assay.
| DeNovo ID | DEN120012 |
| Device Name: | CDC DENV-1-4 REAL TIME RT-PCT ASSAY |
| Classification | Dengue Nucleic Acid Amplification Assay (naat) |
| Applicant | CENTERS FOR DISEASE CONTROL AND PREVENTION 1600 Clifton Rd., N.e. Atlanta, GA 30333 |
| Contact | Hye-joo Kim |
| Product Code | OZB |
| CFR Regulation Number | 866.3946 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | K113336 |
| Review Advisory Board | Microbiology |
| Classification Advisory | Microbiology |
| Type | Post-NSE |
| Date Received | 2012-03-12 |
| Decision Date | 2012-05-24 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |