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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device antigen, c. difficile
Regulation Description Microorganism differentiation and identification device.
Product CodeMCB
Regulation Number 866.2660
Device Class 1


Premarket Reviews
ManufacturerDecision
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
MERIDIAN CO., LTD.
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 2
UNIPATH
  SUBSTANTIALLY EQUIVALENT 1

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

Recalls
Manufacturer Recall Class Date Posted
1 Biosite Inc II Mar-27-2008

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