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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device biuret (colorimetric), total protein
Regulation Description Total protein test system.
Product CodeCEK
Regulation Number 862.1635
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 2
Diagnostic Chemicals Ltd.
  SUBSTANTIALLY EQUIVALENT 1
EASTMAN KODAK
  SUBSTANTIALLY EQUIVALENT 2
EMD
  SUBSTANTIALLY EQUIVALENT 2
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 2
KULZER
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL SPECIALTIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
NOVA
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
TRACE SCIENTIFIC LTD.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Low test results 6
High test results 4
Incorrect or inadequate test results 2
Device Difficult to Setup or Prepare 1
Total Device Problems 13

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

Recalls
Manufacturer Recall Class Date Posted
1 Ortho-Clinical Diagnostics II Nov-15-2013

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