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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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New Search show TPLC since Back to Search Results
Device test, urea (breath or blood)
Product CodeMSQ
Regulation Number 866.3110
Device Class 1


Premarket Reviews
ManufacturerDecision
EXALENZ BIOSCIENCE LTD.
  SUBSTANTIALLY EQUIVALENT 1
MERIDIAN BIOSCIENCE ISRAEL LTD.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

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