Muscular Dystrophy Newborn Screening Test

QJE · Class II — Moderate Risk (510(k) clearance required) · Clinical Chemistry · 21 CFR 862.1506

Classification

FDA Product Code: QJE
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 862.1506
Review panel: CH
Medical specialty: Clinical Chemistry
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 1

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown