OYP — Anti-Jcv Antibody Detection Assay Class II
FDA product code OYP covers "Anti-Jcv Antibody Detection Assay", a Class II medical device regulated under 21 CFR 866.3336. Submissions are reviewed by the Microbiology panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OYP
- Device Class
- Class II
- Regulation Number
- 866.3336
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- 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.