ß-Galactocerebrosidase (Galc) Newborn Screening Test System

QCM · Class II — Moderate Risk (510(k) clearance required) · Clinical Chemistry · 21 CFR 862.1488

Classification

FDA Product Code: QCM
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 862.1488
Review panel: CH
Medical specialty: Clinical Chemistry
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: Y

Definition

For quantitative measurement of the activity of ß-galactocerebrosidase (GALC) from newborn dried blood spot specimens as an aid in screening newborns for Krabbe disease.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 1

Source

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