510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PBKClass II

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

21 CFR 866.3315 / Microbiology
FDA source (opens on fda.gov)

PBK is the FDA product code for Non-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set, a class II device type, regulated under 21 CFR 866.3315. FDA's definition for this code reads: "In vitro qualitative detection of non-variola Orthopoxvirus nucleic acids extracted from human specimens or viral culture". As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PBK
Device name
Non-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set
FDA definition
In vitro qualitative detection of non-variola Orthopoxvirus nucleic acids extracted from human specimens or viral culture.
Regulation
21 CFR 866.3315
Device class
Class II
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
5
Ingested recalls
0

Clearances, product code PBK

By decision year
5 clearances under product code PBK with a decision year between 2018 and 2022, 2022 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code PBK by decision year
YearClearances
20182
20223

Applicants with the most clearances

Product code PBK
Applicants holding the most 510(k) clearances under product code PBK
ApplicantClearances
Centers for Disease Control and Prevention5

Companies listing this code with FDA

Companies whose registered establishments list this code