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510(k) K120986

STRATIFY JCV DXSELECT by Focus Diagnostics, Inc. — Product Code OYP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 2012
Date Received
April 2, 2012
Clearance Type
Traditional
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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Other clearances for product code OYP

  • DEN120008 — STRATIFY JCV(TM) ANTIBODY (January 20, 2012)