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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device radioimmunoassay, testosterones and dihydrotestosterone
Regulation Description Testosterone test system.
Product CodeCDZ
Regulation Number 862.1680
Device Class 1


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 2
BAYER
  SUBSTANTIALLY EQUIVALENT 1
BECKMAN COULTER
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 2
BIOMERIEUX
  SUBSTANTIALLY EQUIVALENT 1
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 1
DIAGNOSTIC PRODUCTS
  SUBSTANTIALLY EQUIVALENT 8
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
DIASORIN
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
ORGANON-TEKNIKA
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 2

Device Problems
Malfunction 5
High test results 3
Low test results 1
Incorrect or inadequate test results 1
False negative result 1
Unknown (for use when the device problem is not known) 1
Total Device Problems 12

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 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II Nov-22-2010

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