Product code PQV
- Device name
- ß-Glucocerebrosidase (Gba) Newborn Screening Test System
- Medical specialty
- Clinical Chemistry
- Device class
- 2
- Regulation number
- 862.1488
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Ineligible
- Definition
- For quantitative measurement of the activity of ß-glucocerebrosidase (GBA) from newborn dried blood spot specimens.
- Source
- FDA openFDA device classification dataset