Acid-Sphingomyelinase (Asm) Newborn Screening Test System
Medical specialty
Clinical Chemistry
Device class
2
Regulation number
862.1488
Review panel
CH
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
Y
Summary malfunction reporting
Ineligible
Definition
For quantitative measurement of the activity of acid-sphingomyelinase (ASM) from newborn dried blood spot specimens as an aid in screening newborns for Niemann-Pick disease.