The following data is part of a De Novo classification by Centers For Disease Control And Prevention (cdc) with the FDA for Variola Virus Real-time Pcr Assay.
| DeNovo ID | DEN160016 |
| Device Name: | Variola Virus Real-Time PCR Assay |
| Classification | Variola Virus Nucleic Acid-based Detection Assay |
| Applicant | CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) 1600 Clifton Road Ne, Ms-c18 Atlanta, GA 30329 |
| Contact | Yon Yu |
| Product Code | PRA |
| CFR Regulation Number | 866.3316 [🔎] |
| 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 | 2016-04-14 |
| Decision Date | 2017-02-06 |
| Reclassification Order: | Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases |