QCM

ß-Galactocerebrosidase (Galc) Newborn Screening Test System

Product code: QCM
Device name: ß-Galactocerebrosidase (Galc) 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 ß-galactocerebrosidase (GALC) from newborn dried blood spot specimens as an aid in screening newborns for Krabbe disease.

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

Official FDA classification page: QCM

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