PQWClass II
Alpha-d-galactosidase A (gla) Newborn Screening Test System
Clinical Chemistry · 21 CFR 862.1488
For quantitative measurement of the activity of alpha-D-galactosidase A (GLA) from newborn dried blood spot specimens.
MDR events0All time
Recalls0All time
Registered firms3Currently listed
510(k) clearances3All time
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
3 firms currently registered for this product code
510(k) clearances
3 clearances for this product code