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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device alpha-l-iduronidase (idua) newborn screening test system
Definition Intended for quantitative measurement of the activity of alpha-L-iduronidase (IDUA) from newborn dried blood spot specimens.
Product CodePQT
Regulation Number 862.1488
Device Class 2

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