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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device test, donor, syphilis, antigens, treponemal
Product CodeMYR
Regulation Number 866.3830
Device Class 2


Premarket Reviews
ManufacturerDecision
IMMUCOR, INC.
  SUBSTANTIALLY EQUIVALENT 1
LAB 21 HEALTHCARE LTD
  SUBSTANTIALLY EQUIVALENT 1
NEWMARKET BIOMEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 2 2
2017 1 1
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 2 2
Insufficient Information 1 1
Cross Reactivity 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 3 3
No Clinical Signs, Symptoms or Conditions 1 1

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