OYP — Anti-Jcv Antibody Detection Assay Class II
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.