Product code PQW

Device name

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

Medical specialty

Clinical Chemistry

Device class

2

Regulation number

862.1488

Review panel

CH

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

Y

Summary malfunction reporting

Ineligible

Definition

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

Source

FDA openFDA device classification dataset