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Tryptase Assay System

FDA product code OYL · 1 cleared devices

Class 2 Immunology
Regulation
21 CFR 866.5760
Review panel
IM
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2018-03-02 – 2018-03-02

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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