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Medical devices; immunology and microbiology devices; classification of John Cunningham Virus serological reagents.
Federal Register
|January 25, 2014
Abstract:
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.
