OYP · Class II · 21 CFR 866.3336

FDA Product Code OYP: Anti-jcv Antibody Detection Assay

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.

2
Total
1
Cleared
75d
Avg days
2012
Since

FDA 510(k) Cleared Anti-jcv Antibody Detection Assay Devices (Product Code OYP)

2 devices
1–2 of 2
No devices found for this product code.

About Product Code OYP - Regulatory Context