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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device test, qualitative and quantitative factor deficiency
Regulation Description Factor deficiency test.
Product CodeGGP
Regulation Number 864.7290
Device Class 2


Premarket Reviews
ManufacturerDecision
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 6
BIOMERIEUX
  SUBSTANTIALLY EQUIVALENT 1
DADE BEHRING
  SUBSTANTIALLY EQUIVALENT 3
DIAGNOSTICA STAGO
  SUBSTANTIALLY EQUIVALENT 2
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 25
KENDALL
  SUBSTANTIALLY EQUIVALENT 2
ORGANON-TEKNIKA
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device operates differently than expected 1
No Known Device Problem 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 1 0 0 1 0 3 0 0 1 1
Class III 1 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 American Diagnostica, Inc. II Apr-21-2010
2 Diagnostica Stago, Inc. III Aug-09-2007
3 Diagnostica Stago, Inc. II Jul-03-2007
4 Instrumentation Laboratory Co. II Feb-01-2016
5 Instrumentation Laboratory Co. II May-10-2012
6 Sekisui Diagnostics Llc II Dec-03-2012
7 Sekisui Diagnostics Llc II Sep-20-2012
8 Siemens Healthcare Diagnostics, Inc. II Dec-22-2015

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