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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device enzyme immunoassay, valproic acid
Regulation Description Neuroleptic drugs radioreceptor assay test system.
Product CodeLEG
Regulation Number 862.3645
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 2
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
BAYER
  SUBSTANTIALLY EQUIVALENT 2
BECKMAN COULTER
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
DADE BEHRING
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
DIAGNOSTIC PRODUCTS
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
ORTHO-CLINICAL
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 5

Device Problems
Incorrect or inadequate test results 3
Low test results 3
Incorrect or inadequate result 1
Total Device Problems 7

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 2 0 0 0 0 1 0
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Bayer Healthcare, LLC (Diagnostics Division) II Jan-17-2007
2 Ortho-Clinical Diagnostics II Feb-08-2012
3 Roche Diagnostics Corp. II Jun-09-2007

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