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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device c.difficile toxin gene amplification assay
Definition Amplification assay for the detection of c. Difficile toxin genes from stool specimens of symptomatic patients.
Product CodeOZN
Regulation Number 866.3130
Device Class 2


Premarket Reviews
ManufacturerDecision
QUIDEL CORP.
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 2

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