Medical devices; immunology and microbiology devices; classification of John Cunningham Virus serological reagents. Final order.
The Food and Drug Administration (FDA) is classifying John Cunningham Virus (JCV) serological reagents into class II (special controls). 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.
D000914:Antibodies, Viral / Q000145:classification*; D018795:Device Approval / Q000331:legislation & jurisprudence*; D004797:Enzyme-Linked Immunosorbent Assay / Q000145:classification*; D004869:Equipment Safety / Q000145:classification*; D006801:Humans; D007158:Immunologic Techniques / Q000145:classification / Q000295:instrumentation; D007577:JC Virus / Q000302:isolation & purification*; D014481:United States; D014773:Virology / Q000145:classification / Q000295:instrumentation*
D000914:Antibodies, Viral