QCMClass II
SS-galactocerebrosidase (galc) Newborn Screening Test System
Clinical Chemistry · 21 CFR 862.1488
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.
MDR events0All time
Recalls0All time
Registered firms1Currently listed
510(k) clearances0All time
Recent MDR events
0 adverse event reports on file
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Event type breakdown
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Most-reported manufacturers
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Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
1 firms currently registered for this product code
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.