title: Medical devices; immunology and microbiology devices; classification of norovirus serological reagents. Final rule.
abstract: The Food and Drug Administration (FDA) is classifying norovirus serological reagents into class II (special controls). The special control that will apply to these devices is the guidance document entitled ``Class II Special Controls Guidance Document: Norovirus Serological Reagents.'' The Agency is classifying these devices into class II (special controls) because special controls, in addition to general controls, will provide a reasonable assurance of safety and effectiveness of these devices and there is sufficient information to establish special controls.
mesh_terms: D017250:Caliciviridae Infections / Q000175:diagnosis; D018795:Device Approval / Q000331:legislation & jurisprudence*; D006801:Humans; D007202:Indicators and Reagents / Q000145:classification*; D029322:Norovirus; D011933:Reagent Kits, Diagnostic / Q000145:classification*; D012698:Serologic Tests / Q000145:classification*; D014481:United States
chemical_list: D007202:Indicators and Reagents; D011933:Reagent Kits, Diagnostic