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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device radioimmunoassay, luteinizing hormone
Regulation Description Luteinizing hormone test system.
Product CodeCEP
Regulation Number 862.1485
Device Class 1


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 2
BIOGENEX
  SUBSTANTIALLY EQUIVALENT 2
Bio-Rad Laboratories
  SUBSTANTIALLY EQUIVALENT 3
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 2
DIAGNOSTIC PRODUCTS
  SUBSTANTIALLY EQUIVALENT 5
Nichols Institute Diagnostics
  SUBSTANTIALLY EQUIVALENT 4
PHAMATECH
  SUBSTANTIALLY EQUIVALENT 1
QUIDEL CORP.
  SUBSTANTIALLY EQUIVALENT 3
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
TAMBRANDS MANUFACTURING, INC.
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
UNIPATH
  SUBSTANTIALLY EQUIVALENT 6
WARNER-LAMBERT CO.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Unknown (for use when the device problem is not known) 3
Other (for use when an appropriate device code cannot be identified) 2
Low test results 1
High Readings 1
Total Device Problems 7

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 0 0 1 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories MPG II Jan-11-2007
2 Beckman Coulter Inc. II Dec-20-2012

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