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 Code | QCM |
Regulation Number |
862.1488
|
Device Class |
2
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