Product code
OZN: C. difficile toxin gene amplification assay
FDA product code · Class II · Microbiology
Key facts
| Product code | OZN |
|---|---|
| Device | C. difficile toxin gene amplification assay |
| Device class | Class II |
| Regulation number | 866.3130 |
| Review panel | Microbiology |
| Medical specialty | Microbiology |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | Amplification assay for the detection of c. Difficile toxin genes from stool specimens of symptomatic patients. |
At a glance
- 10–99 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 10–99 UDI devices (GUDID)
- 10–99 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