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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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


Premarket Reviews
ManufacturerDecision
Bio-Rad Laboratories
  SUBSTANTIALLY EQUIVALENT 14
CENTERS FOR DISEASE CONTROL AND PREVENTION
  SUBSTANTIALLY EQUIVALENT 1
DIAGNOSTIC PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
POLYMEDCO, INC.
  SUBSTANTIALLY EQUIVALENT 1
WAMPOLE LABORATORIES,LLC
  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 0 0 0 0 0 0 0 0 0
Class III 0 1 1 0 2 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Bio-Rad Laboratories III Aug-22-2011
2 Bio-Rad Laboratories III Sep-19-2008
3 Immuno Concepts Inc III Apr-06-2009
4 Inova Diagnostics Incorporated III Nov-23-2011

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