PBK

Non-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set

Product code: PBK
Device name: Non-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set
Device class: Class 2
21 CFR: 21 CFR 866.3315
Medical specialty: Microbiology
Marketing pathway: 510(K)
510(k) clearances (all years, FDA): 5 (all years; only the last 3 years are listed here)

FDA classification definition

In vitro qualitative detection of non-variola Orthopoxvirus nucleic acids extracted from human specimens or viral culture.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: PBK

Classification and pathway per current FDA publications. Data from openFDA (CC0).