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

FDA product code PQW · Class II (moderate risk) · 21 CFR 862.1488 · Clinical Chemistry

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

2510(k) clearances
0PMA approvals
0recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K190266NeoLSD MSMS KitPQW · Traditional Perkinelmer, Inc.05/03/2019SE
K173829NeoLSD MSMS kitPQW · Traditional Wallac Oy, A Subsidiary of Perkinelmer07/18/2018SE