# Tryptase Assay System
> **Product code: OYL** · Class II — Moderate Risk (510(k) clearance required) · Immunology · 21 CFR 866.5760
## Classification
- **FDA Product Code:** OYL
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 866.5760
- **Review panel:** IM
- **Medical specialty:** Immunology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** Y
## 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.

## Market data
- **Cleared 510(k) submissions:** 2
- **Registered establishments:** 2
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=OYL)
---
*AI Analytics · CC0 1.0*