QCLClass II
Acid-sphingomyelinase (asm) Newborn Screening Test System
Clinical Chemistry · 21 CFR 862.1488
For quantitative measurement of the activity of acid-sphingomyelinase (ASM) from newborn dried blood spot specimens as an aid in screening newborns for Niemann-Pick 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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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.