PBK — Non-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set Class II
Classification Details
- Product Code
- PBK
- Device Class
- Class II
- Regulation Number
- 866.3315
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Definition
In vitro qualitative detection of non-variola Orthopoxvirus nucleic acids extracted from human specimens or viral culture.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K222558 | centers for disease control and prevention | Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set | August 30, 2022 |
| K221834 | centers for disease control and prevention | Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set | June 24, 2022 |
| K221658 | centers for disease control and prevention | Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set | June 10, 2022 |
| DEN070001 | centers for disease control and prevention | NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SET | September 21, 2018 |
| K181205 | centers for disease control and prevention | Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set | September 20, 2018 |