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U.S. Department of Health and Human Services

Product Classification

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Device acid-sphingomyelinase (asm) newborn screening test system
Definition 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.
Physical State Neonatal screening test, in vitro diagnostic test
Technical Method Quantitative enzymatic assay
Target Area Newborn dried blood spot specimens
Regulation Medical Specialty Clinical Chemistry
Review Panel Clinical Chemistry
Product CodeQCL
Premarket Review Division of Chemistry and Toxicology Devices (DCTD)
Division of Chemistry and Toxicology Devices (DCTD)
Submission Type 510(k)
Regulation Number 862.1488
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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