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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device kit, test, pregnancy, hcg, over the counter
Regulation Description Human chorionic gonadotropin (HCG) test system.
Product CodeLCX
Regulation Number 862.1155
Device Class 2


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 1
ABBOTT
  SUBSTANTIALLY EQUIVALENT 4
BIOGENEX
  SUBSTANTIALLY EQUIVALENT 1
CHURCH & DWIGHT CO., INC.
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
ORGANON-TEKNIKA
  SUBSTANTIALLY EQUIVALENT 1
PHAMATECH
  SUBSTANTIALLY EQUIVALENT 5
QUIDEL CORP.
  SUBSTANTIALLY EQUIVALENT 9
TAIDOC TECHNOLOGY CORPORATION
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
TAMBRANDS MANUFACTURING, INC.
  SUBSTANTIALLY EQUIVALENT 1
UNIPATH
  SUBSTANTIALLY EQUIVALENT 11
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 9

Device Problems
Low test results 2
Total Device Problems 2

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 0 0 1 0 0 0
Class III 1 0 0 1 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Inverness Medical Professional Diagnostics III Sep-25-2010
2 Mainline Technology, Inc. II Mar-08-2010
3 Mizuho USA, Inc. III Jan-05-2007

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