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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device kit, screening, urine
Regulation Description Microorganism differentiation and identification device.
Product CodeJXA
Regulation Number 866.2660
Device Class 1


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
BIOMERIEUX
  SUBSTANTIALLY EQUIVALENT 1
E-Z-EM, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Incorrect or inadequate result 13
False negative result 3
Contamination during use 1
Output issue 1
Total Device Problems 18

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