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FDA PRODUCT CODE · CLASS II

QCL — Acid-Sphingomyelinase (Asm) Newborn Screening Test System

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.

DEVICE CLASS
Class II
REGULATION
21 CFR 862.1488
MEDICAL SPECIALTY
Clinical Chemistry
REVIEW PANEL
CH
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
0
510(K)/PMA CLEARANCES
0
RECALL ENTRIES

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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