Medical devices; immunology and microbiology devices; classification of AFP-L3% immunological test systems. Final rule.
The Food and Drug Administration (FDA) is classifying AFP-L3% (alpha-fetoprotein L3 subfraction) immunological test systems into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: AFP-L3% Immunological Test Systems." The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special control for the device.
D018795:Device Approval / Q000331:legislation & jurisprudence; D004869:Equipment Safety / Q000145:classification / Q000295:instrumentation; D006801:Humans; D007158:Immunologic Techniques / Q000145:classification* / Q000295:instrumentation; D014481:United States; D014486:United States Food and Drug Administration; D000509:alpha-Fetoproteins / Q000737:chemistry
D000509:alpha-Fetoproteins