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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device test,natriuretic peptide
Regulation Description B-type natriuretic peptide test system.
Product CodeNBC
Regulation Number 862.1117
Device Class 2


Premarket Reviews
ManufacturerDecision
BAYER
  SUBSTANTIALLY EQUIVALENT 3
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 2
BIOMERIEUX
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
DADE BEHRING
  SUBSTANTIALLY EQUIVALENT 4
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 2
I-STAT
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
ORTHO-CLINICAL
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 4
SIEMENS
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1

Device Problems
Incorrect or inadequate test results 19
Low test results 18
False negative result 2
High test results 1
Total Device Problems 40

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 1 0
Class II 0 0 0 1 0 4 0
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Point Of Care Inc. II Aug-09-2012
2 Alere San Diego, Inc. I Jul-06-2012
3 Siemens Healthcare Diagnostics, Inc II Dec-11-2012
4 Siemens Healthcare Diagnostics, Inc II Sep-06-2012
5 Siemens Healthcare Diagnostics, Inc. II May-10-2012
6 Siemens Healthcare Diagnostics, Inc. II Nov-24-2010

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