PQT

Alpha-L-Iduronidase (Idua) Newborn Screening Test System

Product code

PQT

Device name

Alpha-L-Iduronidase (Idua) Newborn Screening Test System

Device class

Class 2

21 CFR

21 CFR 862.1488

Medical specialty

Clinical Chemistry

Marketing pathway

510(K)

Flag

Third-party review eligible

FDA classification definition

Intended for quantitative measurement of the activity of alpha-L-iduronidase (IDUA) from newborn dried blood spot specimens.

Definition text from the FDA device classification database (U.S. federal government work, public domain).