Device |
alpha-d-galactosidase a (gla) newborn screening test system |
Definition |
For quantitative measurement of the activity of alpha-D-galactosidase A (GLA) from newborn dried blood spot specimens. |
Physical State |
Neonatal screening test |
Technical Method |
Quantitative fluorimetric enzymatic activity assay. |
Target Area |
Newborn dried blood spot specimens. |
Regulation Medical Specialty |
Clinical Chemistry |
Review Panel |
Clinical Chemistry |
Product Code | PQW |
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
|