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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
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
FOCUS DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
GREAT BASIN SCIENTIFIC
  GRANTED 1
MERIDIAN BIOSCIENCE, INC.
  SUBSTANTIALLY EQUIVALENT 2

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