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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device enzyme linked immunoabsorbent assay, mumps virus
Regulation Description Mumps virus serological reagents.
Product CodeLJY
Regulation Number 866.3380
Device Class 1


Premarket Reviews
ManufacturerDecision
BIOMERIEUX
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Incorrect or inadequate result 3
Total Device Problems 3

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 1 0 0 0 0 0 1
Class III 0 0 0 0 0 1 1 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Bion Enterprises Ltd III Jun-05-2013
2 Calbiotech Inc II Mar-05-2010
3 Diamedix Corporation II May-16-2016
4 Zeus Scientific, Inc. III May-08-2012

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