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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device anti-jcv antibody detection assay
Regulation Description John Cunningham Virus serological reagents.
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.
Product CodeOYP
Regulation Number 866.3336
Device Class 2

Device Problems
False positive result 1
Total Device Problems 1

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 0 1 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Focus Diagnostics Inc II Apr-17-2015

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