Product code PBK— Microbiology
Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
- Classification name
- Non-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set
- Device class
- Class 2
- Regulation
- 21 CFR 866.3315
- Advisory panel
- Microbiology
- Total cleared
- 5
- First cleared
- Most recent
FDA classification definition
“In vitro qualitative detection of non-variola Orthopoxvirus nucleic acids extracted from human specimens or viral culture.”
Market context for product code PBK
FDA has cleared devices under product code PBK between 2018 and 2022, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2022
- 2018
Top applicants under product code PBK
Recent clearances under product code PBK
- K222558 — Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
- K221834 — Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
- K221658 — Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
- DEN070001 — NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SET
- K181205 — Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
Data sourced from openFDA. This site is unofficial and independent of the FDA.