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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device gram negative identification panel
Regulation Description Microorganism differentiation and identification device.
Product CodeLQM
Regulation Number 866.2660
Device Class 1


Premarket Reviews
ManufacturerDecision
BIOMERIEUX
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Incorrect or inadequate result 2
No code available 2
Total Device Problems 4

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