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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device ß-galactocerebrosidase (galc) newborn screening test system
Definition For quantitative measurement of the activity of ß-galactocerebrosidase (GALC) from newborn dried blood spot specimens as an aid in screening newborns for Krabbe disease.
Product CodeQCM
Regulation Number 862.1488
Device Class 2

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