PBK · Non-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set
Microbiology · 21 CFR 866.3315 · Class 2
Overview
| Product Code | PBK |
|---|---|
| Device Name | Non-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set |
| Regulation | 21 CFR 866.3315 |
| Device Class | Class 2 |
| Review Panel | Microbiology |
Identification
In vitro qualitative detection of non-variola Orthopoxvirus nucleic acids extracted from human specimens or viral culture.
Recent Cleared Devices (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K222558 | Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set | Centers for Disease Control and Prevention | Aug 30, 2022 | SESE |
| K221834 | Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set | Centers for Disease Control and Prevention | Jun 24, 2022 | SESE |
| K221658 | Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set | Centers for Disease Control and Prevention | Jun 10, 2022 | SESE |
| DEN070001 | NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SET | Centers for Disease Control and Prevention | Sep 21, 2018 | DENG |
| K181205 | Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set | Centers for Disease Control and Prevention | Sep 20, 2018 | SESE |
Top Applicants
- Centers for Disease Control and Prevention — 5 clearances
