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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, nucleic acid amplification test, dna, antimicrobial resistance marker, direct specimen
Definition To detect the presence of genetic markers of antimicrobial resistance by testing directly from clinical specimens using nucleic acid amplification technology.
Product CodePOC
Regulation Number 866.1640
Device Class 2


Premarket Reviews
ManufacturerDecision
CEPHEID
  SUBSTANTIALLY EQUIVALENT 2
CHECK-POINTS HEALTH B.V.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 1 1
2022 1 1
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 3 3
Incorrect, Inadequate or Imprecise Result or Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4 4

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