QCMClass II
ß-Galactocerebrosidase (Galc) Newborn Screening Test System
21 CFR 862.1488 / Clinical Chemistry
QCM is the FDA product code for ß-Galactocerebrosidase (Galc) Newborn Screening Test System, a class II device type, regulated under 21 CFR 862.1488. FDA's definition for this code reads: "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". As of , FDA records hold no 510(k) clearances under this code and no recalls.
Classification record
- Product code
- QCM
- Device name
- ß-Galactocerebrosidase (Galc) Newborn Screening Test System
- FDA 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.
- Regulation
- 21 CFR 862.1488
- Device class
- Class II
- Review panel
- Clinical Chemistry
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 0
- Ingested recalls
- 0
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.