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Alpha-D-Galactosidase A (Gla) Newborn Screening Test System

FDA product code PQW · 2 cleared devices

Class 2 Clinical Chemistry
Regulation
21 CFR 862.1488
Review panel
CH
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2018-07-18 – 2019-05-03

For quantitative measurement of the activity of alpha-D-galactosidase A (GLA) from newborn dried blood spot specimens.

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