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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device antigens, cf (including cf control), influenza virus a, b, c
Regulation Description Influenza virus serological reagents.
Product CodeGNX
Regulation Number 866.3330
Device Class 1


Premarket Reviews
ManufacturerDecision
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
BD
  SUBSTANTIALLY EQUIVALENT 17
FISHER SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
GENZYME CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
INVERNESS
  SUBSTANTIALLY EQUIVALENT 1
MERIDIAN CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
QUIDEL CORP.
  SUBSTANTIALLY EQUIVALENT 9
REMEL INC
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 2
THERMO BIOSTAR, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
False positive result 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 1 0 0 0 1 1 0 0 0
Class III 0 0 0 0 0 0 1 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Binax, Inc. dba IMPD II May-23-2007
2 Inverness Medical BioStar Inc. II Nov-03-2008
3 Princeton Biomeditech Corp II Aug-31-2012
4 Quidel Corporation II Feb-14-2013
5 Remel Inc III Aug-13-2013

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