OYL — Tryptase Assay System Class II

FDA Device Classification

Classification Details

Product Code: OYL
Device Class: Class II
Regulation Number: 866.5760
Submission Type
Review Panel: IM
Medical Specialty: Immunology
Implant: No

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.

Recent 510(k) Clearances

K-Number	Applicant	Device Name	Date
K173704	phadia	ImmunoCAP Tryptase, ImmunoCAP Tryptase Calibrators, ImmunoCAP Tryptase Curve Con	March 2, 2018
DEN120001	phadia us	IMMUNOCAP TRYPTASE, CALIBRATORS, CURVE CONTROL, CONJUGATE 50, CALIBRATOR STRIP,	February 15, 2012