Anti-Jcv Antibody Detection Assay
The Anti-JCV Antibody Detection Assay is an in vitro diagnostic device intended for the detection of antibodies to the John Cunningham virus (JCV) in serum or plasma samples from multiple sclerosis and Crohn's disease patients receiving immunomodulatory therapies, to assess risk of progressive multifocal leukoencephalopathy (PML). It is classified as Class 2 (FDA Class 2), requiring 510(k) premarket clearance. The product code is OYP, with regulation number 866.3336 under the Microbiology medical specialty.
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Basic Information
- Product Code
- OYP
- Device Class
- FDA class 2
- Regulation Number
- 866.3336
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.