# ß-Galactocerebrosidase (Galc) Newborn Screening Test System
> **Product code: 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
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=QCM)
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