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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device antinuclear antibody, antigen, control
Regulation Description Antinuclear antibody immunological test system.
Product CodeLKJ
Regulation Number 866.5100
Device Class 2


Premarket Reviews
ManufacturerDecision
Bio-Rad Laboratories
  SUBSTANTIALLY EQUIVALENT 10
DIAGNOSTIC PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1

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

Recalls
Manufacturer Recall Class Date Posted
1 Bio-Rad Laboratories II Jun-11-2008
2 Bio-Rad Laboratories Inc II Mar-02-2011
3 Bio-Rad Laboratories Inc II Mar-02-2011
4 Bio-Rad Laboratories Inc III Dec-13-2010
5 Bio-Rad Laboratories Inc II Dec-13-2010
6 Bio-Rad Laboratories Inc II Dec-13-2010
7 Bio-Rad Laboratories Inc II Dec-06-2010

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