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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
Regulation Description Clostridium 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
FOCUS DIAGNOSTICS, INC.: DBA DIASORIN MOLECULAR LLC
  SUBSTANTIALLY EQUIVALENT 1
GENEPOC INC.
  SUBSTANTIALLY EQUIVALENT 1
LUMINEX CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
QUIDEL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ROCHE MOLECULAR SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2021 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Resultor Readings 4 4
False Positive Result 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3 3
Insufficient Information 2 2
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Luminex Corporation II Aug-15-2019
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