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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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Device test,qualitative,for hla,non-diagnostic
Definition CBER
Product CodeMZI
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
BD
  SUBSTANTIALLY EQUIVALENT 2
BIOMERIEUX
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device operates differently than expected 94
Incorrect or inadequate test results 18
False positive result 6
No Known Device Problem 2
Total Device Problems 120

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