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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
Regulation Description Nucleic acid-based device for the amplification, detection, and identification of microbial pathogens directly from whole blood specimens.
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
T2BIOSYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2022 7 7
2023 17 17
2024 31 31

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 34 34
False Negative Result 26 26

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 53 53
Insufficient Information 2 2

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