title: Medical devices; immunology and microbiology devices; classification of tryptase test system. Final order.
abstract: The Food and Drug Administration (FDA) is classifying tryptase test system devices into class II (special controls). The Agency is classifying the device into class II (special controls) because special controls, in addition to general controls, will provide a reasonable assurance of safety and effectiveness of the device.
mesh_terms: D018795:Device Approval / Q000331:legislation & jurisprudence*; D006801:Humans; D034721:Mastocytosis, Systemic / Q000175:diagnosis*; D011933:Reagent Kits, Diagnostic / Q000145:classification*; D053802:Tryptases / Q000145:classification*; D014481:United States
chemical_list: D011933:Reagent Kits, Diagnostic; D053802:Tryptases