FDA Product Code OYL: Tryptase Assay System
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.
Leading manufacturers include Phadia US, Inc. and Phadia AB.
2
Total
1
Cleared
61d
Avg days
2012
Since
FDA 510(k) Cleared Tryptase Assay System Devices (Product Code OYL)
2 devices
Cleared
Mar 02, 2018
ImmunoCAP Tryptase, ImmunoCAP Tryptase Calibrators, ImmunoCAP Tryptase Curve Control, ImmunoCAP Tryptase Conjugate 50, ImmunoCAP Tryptase Calibrator Strip, ImmunoCAP Tryptase Curve Control Strip
Phadia AB
Immunology
88d
Not Cleared
Feb 15, 2012
IMMUNOCAP TRYPTASE, CALIBRATORS, CURVE CONTROL, CONJUGATE 50, CALIBRATOR STRIP, CURVE CONTROL STRIP, ANTI-TRYPTASE
Phadia US, Inc.
Immunology
34d