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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device nadh oxidation/nad reduction, ast/sgot
Regulation Description Aspartate amino transferase (AST/SGOT) test system.
Product CodeCIT
Regulation Number 862.1100
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 7
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
BAYER
  SUBSTANTIALLY EQUIVALENT 1
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 3
Diagnostic Chemicals Ltd.
  SUBSTANTIALLY EQUIVALENT 1
DOW
  SUBSTANTIALLY EQUIVALENT 3
EASTMAN KODAK
  SUBSTANTIALLY EQUIVALENT 1
EMD
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 1
KULZER
  SUBSTANTIALLY EQUIVALENT 2
MEDICAL SPECIALTIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHO-CLINICAL
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 6
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
TRACE SCIENTIFIC LTD.
  SUBSTANTIALLY EQUIVALENT 4

Device Problems
Mislabeled 23
Incorrect or inadequate result 18
Error or warning message, failure to produce 4
Device displays error message 4
Low test results 2
High Readings 1
Total Device Problems 52

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

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories Inc. II Apr-23-2012
2 Horiba Instruments, Inc dba Horiba Medical II Jan-03-2013
3 Pointe Scientific, Inc. II Oct-22-2008

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