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U.S. Department of Health and Human Services

Product Classification

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Device tryptase assay system
Regulation Description Tryptase test system.
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.
Physical State n/a
Technical Method Immunoassay
Target Area plasma and serum samples
Regulation Medical Specialty Immunology
Review Panel Immunology
Product CodeOYL
Premarket Review Division of Immunology and Hematology Devices (DIHD)
Division of Immunology and Hematology Devices (DIHD)
Submission Type 510(k)
Regulation Number 866.5760
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons