The following data is part of a De Novo classification by Centers For Disease Control And Prevention with the FDA for Non-variola Orthopoxvirus Real-time Pcr Primer And Probe Set.
| DeNovo ID | DEN070001 |
| Device Name: | NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SET |
| Classification | Non-variola Orthopoxvirus Real-time Pcr Primer And Probe Set |
| Applicant | CENTERS FOR DISEASE CONTROL AND PREVENTION 1600 Clifton Rd., N.e. Atlanta, GA 30333 |
| Contact | Hye-joo Kim |
| Product Code | PBK |
| CFR Regulation Number | 866.3315 [🔎] |
| 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 | Post-NSE |
| Date Received | 2007-01-16 |
| Decision Date | 2018-09-21 |
| 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 |