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U.S. Department of Health and Human Services

Product Classification

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Device tryptase assay 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 Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.5760
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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