DEN070001 is an FDA 510(k) submission for the NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SET. This device is classified as a Non-variola Orthopoxvirus Real-time Pcr Primer And Probe Set (Class II - Special Controls, product code PBK).
Submitted by Centers For Disease Control and Prevention (Atlanta, US). The FDA issued a Not Cleared (DENG) decision on September 21, 2018.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3315. In Vitro Qualitative Detection Of Non-variola Orthopoxvirus Nucleic Acids Extracted From Human Specimens Or Viral Culture..
| 510(k) Number | DEN070001 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | January 16, 2007 |
| Decision Date | September 21, 2018 |
| Days to Decision | 4266 days |
| Submission Type | Post-NSE |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | PBK — Non-variola Orthopoxvirus Real-time Pcr Primer And Probe Set |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3315 |
| Definition | In Vitro Qualitative Detection Of Non-variola Orthopoxvirus Nucleic Acids Extracted From Human Specimens Or Viral Culture. |