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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device kit, cell screening, fetal
Product CodeMTI
Device Class Not Classified


Premarket Reviews
ManufacturerDecision
ALBA BIOSCIENCE LIMITED (DOING BUSINESS AS QUOTIENT)
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Component Missing 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1 1

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