PBK
5 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Non-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3315
- Medical specialty
- Microbiology
- FDA definition
- In vitro qualitative detection of non-variola Orthopoxvirus nucleic acids extracted from human specimens or viral culture.
Download CSV table Client report (share link) ◉ Watch
Both buttons carry the same predicate table: the CSV downloads for your worksheet, the report is a shareable page for clients. Exports: 3 free/month with an account · reports & watching free.
Building a predicate table? Click + Add on candidates below (up to 8), then compare and export from your Builder.
| Record | Firm | Date | Builder |
|---|---|---|---|
| Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set (K222558) | Centers for Disease Control and Prevention | 2022-08-30 | + Add |
| Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set (K221834) | Centers for Disease Control and Prevention | 2022-06-24 | + Add |
| Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set (K221658) | Centers for Disease Control and Prevention | 2022-06-10 | + Add |
| NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SET (DEN070001) | Centers for Disease Control and Prevention | 2018-09-21 | |
| Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set (K181205) | Centers for Disease Control and Prevention | 2018-09-20 | + Add |
Track PBK automatically
Every clearance here is in the API, with alerts when new ones post.