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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device c. difficile nucleic acid amplification test assay
Regulation Description Microorganism differentiation and identification device.
Definition In vitro diagnostic test for the qualitative detection of toxigenic clostridium difficile nucleic acids isolated and purified from stool specimens obtained from symptomatic patients.
Product CodeOMN
Regulation Number 866.2660
Device Class 1


Premarket Reviews
ManufacturerDecision
Cepheid
  SUBSTANTIALLY EQUIVALENT 1
MERIDIAN CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2

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

Recalls
Manufacturer Recall Class Date Posted
1 Meridian Bioscience Inc II Jun-27-2014

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