OYP
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Anti-Jcv Antibody Detection Assay
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3336
- Medical specialty
- Microbiology
- FDA 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.
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| Record | Firm | Date |
|---|---|---|
| STRATIFY JCV DXSELECT (K120986) | Focus Diagnostics, Inc. | 2012-08-16 |
| STRATIFY JCV(TM) ANTIBODY (DEN120008) | Focus Diagnostics, Inc. | 2012-01-20 |
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