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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, donor, syphilis, antigens, treponemal
Product CodeMYR
Regulation Number 866.3830
Device Class 2


Premarket Reviews
ManufacturerDecision
NEWMARKET BIOMEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 1 1
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Cross Reactivity 1 1
Insufficient Information 1 1

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

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