Product code
OYP: Anti-jcv antibody detection assay
FDA product code · Class II · Microbiology
Key facts
| Product code | OYP |
|---|---|
| Device | Anti-jcv antibody detection assay |
| Device class | Class II |
| Regulation number | 866.3336 |
| Review panel | Microbiology |
| Medical specialty | Microbiology |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | The anti-jcv antibody detection assay is intended for the detection of antibodies to the john cunningham virus (jcv) in serum or plasma samples from multiple sclerosis (ms) and crohn's disease (cd) patients receiving immunomodulatory therapies. |
At a glance
- 1–9 510(k) clearances
- 1–9 De Novo grants
- None PMA approvals
- None HDE approvals
- 1–9 UDI devices (GUDID)
- 1–9 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