QCL — Acid-Sphingomyelinase (Asm) Newborn Screening Test System Class II
FDA product code QCL covers "Acid-Sphingomyelinase (Asm) Newborn Screening Test System", a Class II medical device regulated under 21 CFR 862.1488. Submissions are reviewed by the Clinical Chemistry panel.
Classification Details
- Product Code
- QCL
- Device Class
- Class II
- Regulation Number
- 862.1488
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
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.