QCL

Acid-Sphingomyelinase (Asm) Newborn Screening Test System

Product code: QCL
Device name: Acid-Sphingomyelinase (Asm) Newborn Screening Test System
Device class: Class 2
21 CFR: 21 CFR 862.1488
Medical specialty: Clinical Chemistry
Marketing pathway: 510(K)
Flag: Third-party review eligible

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: QCL

Classification and pathway per current FDA publications. Data from openFDA (CC0).