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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device diazonium colorimetry, urobilinogen (urinary, non-quant.)
Regulation Description Urinary urobilinogen (nonquantitative) test system.
Product CodeCDM
Regulation Number 862.1785
Device Class 1

Device Problems
False negative result 4
Device operates differently than expected 4
Total Device Problems 8

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