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.

Leading manufacturers include Focus Diagnostics, Inc..

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
Cleared Aug 16, 2012
STRATIFY JCV DXSELECT
K120986
Focus Diagnostics, Inc.
Microbiology · 136d
Not Cleared Jan 20, 2012
STRATIFY JCV(TM) ANTIBODY
DEN120008
Focus Diagnostics, Inc.
Microbiology · 14d

About Product Code OYP - Regulatory Context