OYL

2 FDA 510(k) clearances · Product code

FDA profile

Official device name

Tryptase Assay System

Device class

Class II (moderate risk)

Regulation

21 CFR 866.5760

Medical specialty

Immunology

Flags

Third-party review eligible

FDA 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.

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