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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device urease and glutamic dehydrogenase, urea nitrogen
Regulation Description Urea nitrogen test system.
Product CodeCDQ
Regulation Number 862.1770
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 4
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 4
Diagnostic Chemicals Ltd.
  SUBSTANTIALLY EQUIVALENT 3
EMD
  SUBSTANTIALLY EQUIVALENT 4
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 2
KENDALL
  SUBSTANTIALLY EQUIVALENT 1
KULZER
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
TRACE SCIENTIFIC LTD.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Low test results 204
High test results 201
Incorrect or inadequate test results 3
Mechanical issue 2
Total Device Problems 410

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

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories, Inc II Nov-16-2011
2 Siemens Healthcare Diagnostics, Inc. II May-06-2016

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