PQW

Alpha-D-Galactosidase A (Gla) Newborn Screening Test System

Product code

PQW

Device name

Alpha-D-Galactosidase A (Gla) 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

510(k) clearances (all years, FDA)

3 (all years; only the last 3 years are listed here)

FDA classification definition

For quantitative measurement of the activity of alpha-D-galactosidase A (GLA) from newborn dried blood spot specimens.

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