PQW — Alpha-D-Galactosidase A (Gla) Newborn Screening Test System Class II
FDA product code PQW covers "Alpha-D-Galactosidase A (Gla) Newborn Screening Test System", a Class II medical device regulated under 21 CFR 862.1488. Submissions are reviewed by the Clinical Chemistry panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PQW
- 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 alpha-D-galactosidase A (GLA) from newborn dried blood spot specimens.