Product code
NVQ: Bacteriophage and controls, b. anthracis lysis
FDA product code · Class II · Microbiology
Key facts
| Product code | NVQ |
|---|---|
| Device | Bacteriophage and controls, b. anthracis lysis |
| Device class | Class II |
| Regulation number | 866.3045 |
| Review panel | Microbiology |
| Medical specialty | Microbiology |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | A gamma phage lysis assay intended for the identification of bacillus anthracis from non-hemolytic, aerobic gram positive colonies isolated from sheep blood agar. To aid in the laboratory identification of bacillus anthracis culture growth by lysis with a specific bacteriophage. |
At a glance
- 1–9 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- None UDI devices (GUDID)
- None MAUDE adverse event reports
- 1–9 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