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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system,detection,bacterial, for platelet transfusion products
Regulation Description Microbial growth monitor.
Definition Cber
Product CodeMZC
Regulation Number 866.2560
Device Class 1


Premarket Reviews
ManufacturerDecision
BIOMERIEUX
  SUBSTANTIALLY EQUIVALENT 9
PALL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
False negative result 6
False reading from device non-compliance 2
No Information 2
Leak 1
Total Device Problems 11

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