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510(k) DEN120008

STRATIFY JCV(TM) ANTIBODY by Focus Diagnostics, Inc. — Product Code OYP

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
January 20, 2012
Date Received
January 6, 2012
Clearance Type
Post-NSE
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Anti-Jcv Antibody Detection Assay
Device Class
Class II
Regulation Number
866.3336
Review Panel
MI
Submission Type

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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  • K120986 — STRATIFY JCV DXSELECT (August 16, 2012)
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Other clearances for product code OYP

  • K120986 — STRATIFY JCV DXSELECT (August 16, 2012)