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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device phenotypic test kit, non-susceptible/elevated mic organisms, cultured isolates
Definition Qualitative detection of carbapenemase enzymes in pure colonies of Enterobacteriaceae and Pseudomonas aeruginosa that have elevated MIC values to any Carbapenem
Product CodePTJ
Regulation Number 866.1640
Device Class 2


Premarket Reviews
ManufacturerDecision
NG BIOTECH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 2 2
2020 2 2
2021 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 8 8
Incorrect, Inadequate or Imprecise Result or Readings 2 2
False Negative Result 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 8 8
No Patient Involvement 2 2
No Known Impact Or Consequence To Patient 2 2

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