Product code OYL
- Device name
- Tryptase Assay System
- Medical specialty
- Immunology
- Device class
- 2
- Regulation number
- 866.5760
- Review panel
- IM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Definition
- An in vitro diagnostic device intended as an aid in the clinical diagnosis of patients with a suspicion of systemic mastocytosis in conjunction with other clinical and laboratory findings.
- Source
- FDA openFDA device classification dataset