QJE

Muscular Dystrophy Newborn Screening Test

Product code

QJE

Device name

Muscular Dystrophy Newborn Screening Test

Device class

Class 2

21 CFR

21 CFR 862.1506

Medical specialty

Clinical Chemistry

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification definition

A muscular dystrophy newborn screening test is intended to measure creatine kinase levels obtained from dried blood spot specimens on filter paper from newborns as an aid in screening newborns for muscular dystrophy.

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