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SPECIAL CONTROLS DOCUMENT

Class II Special Controls Guideline: Tryptase Test System as an Aid in the Diagnosis of Systemic Mastocytosis Guideline for Industry and Food and Drug Administration Staff September 2014

Final

Class II Special Controls Guideline: Tryptase Test System as an Aid in the Diagnosis of Systemic Mastocytosis

Docket Number:
FDA-2014-N-1251
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This document was developed as a special controls guideline to support the classification of a tryptase test system into class II (special controls). A tryptase test system is a device that aids in the diagnosis of systemic mastocytosis. It is intended for in vitro diagnostic use 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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