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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, herpes simplex virus, non-specific
Regulation Description Herpes simplex virus serological assays.
Product CodeLGC
Regulation Number 866.3305
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
DIAGNOSTIC PRODUCTS
  SUBSTANTIALLY EQUIVALENT 2
EASTMAN KODAK
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
False negative 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 1 0 1 1 0 0 0 0 0
Class III 0 0 0 0 0 1 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 BioCheck Inc II Mar-11-2011
2 Biokit U.S.A. Inc. II Jul-08-2010
3 Diamedix Corporation III May-10-2012
4 Focus Diagnostics Inc II Aug-17-2008

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