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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device cardiac c-reactive protein, antigen, antiserum, and control
Regulation Description C-reactive protein immunological test system.
Definition In vitro diagnostic test to measure C-reactive protein for the purpose of making cardiac risk assessments.
Product CodeNQD
Regulation Number 866.5270
Device Class 2


Premarket Reviews
ManufacturerDecision
BECKMAN COULTER
  SUBSTANTIALLY EQUIVALENT 2
DADE BEHRING
  SUBSTANTIALLY EQUIVALENT 5
DIAGNOSTIC PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 2
ORTHO-CLINICAL
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Low test results 2
Incorrect or inadequate result 1
Malfunction 1
High test results 1
Total Device Problems 5

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

Recalls
Manufacturer Recall Class Date Posted
1 Siemens Healthcare Diagnostics Inc II Jan-07-2016

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