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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device direct blood bacterial nucleic acid detection system
Definition Amplification, detection and identification of microbial pathogens directly from whole blood specimens
Product CodeQBX
Regulation Number 866.3960
Device Class 2


Premarket Reviews
ManufacturerDecision
T2 BIOSYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2022 7 7
2023 17 17
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 16 16
False Positive Result 13 13

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 25 25
Insufficient Information 2 2

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