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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search Show TPLC since Back To Search Results
Device kit, screening, urine
Regulation Description Microorganism differentiation and identification device.
Product CodeJXA
Regulation Number 866.2660
Device Class 1

Device Problems
Incorrect, Inadequate or Imprecise Result or Readings 21
False Negative Result 4
Contamination During Use 3
Device Markings / Labelling Problem 1
Output Problem 1
Incorrect Or Inadequate Test Results 1
Total Device Problems 31


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