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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device urinalysis controls (assayed and unassayed)
Regulation Description Quality control material (assayed and unassayed).
Product CodeJJW
Regulation Number 862.1660
Device Class 1


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
BAYER
  SUBSTANTIALLY EQUIVALENT 1
Bio-Rad Laboratories
  SUBSTANTIALLY EQUIVALENT 5
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 1
KULZER
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Device Cleaning Issue 1
False positive result 1
Total Device Problems 2

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 1 0 0 0 3 1 0 0
Class III 0 0 0 0 0 1 2 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Assuramed II Sep-13-2013
2 Iris Diagnostics II May-15-2013
3 Iris Diagnostics III Aug-01-2012
4 Lin-Zhi International Inc II Mar-12-2014
5 Quantimetrix Corporation II Jan-17-2009
6 Siemens Healthcare Diagnostics Inc II Jan-04-2013
7 Siemens Healthcare Diagnostics Inc III Jan-04-2013
8 Thermofisher Scientive III Nov-22-2013

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