Product code QJE

Device name

Muscular Dystrophy Newborn Screening Test

Medical specialty

Clinical Chemistry

Device class

2

Regulation number

862.1506

Review panel

CH

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset