Product code
PBK: Non-variola orthopoxvirus real-time pcr primer and probe set
FDA product code · Class II · Microbiology
Key facts
| Product code | PBK |
|---|---|
| Device | Non-variola orthopoxvirus real-time pcr primer and probe set |
| Device class | Class II |
| Regulation number | 866.3315 |
| Review panel | Microbiology |
| Medical specialty | Microbiology |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | In vitro qualitative detection of non-variola Orthopoxvirus nucleic acids extracted from human specimens or viral culture. |
At a glance
- 1–9 510(k) clearances
- 1–9 De Novo grants
- None PMA approvals
- None HDE approvals
- 1–9 UDI devices (GUDID)
- None MAUDE adverse event reports
- None Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database