Medical Devices; Immunology and Microbiology Devices; Classification of John Cunningham Virus Serological Reagents
fda-device · Food and Drug Administration · Rule · Published 2014-01-23 · Effective 2014-02-24 · 79 FR 3739
Document
Document number
2014-01216
Federal Register citation
79 FR 3739
CFR reference
21 CFR 866
Type
Rule
Action
Final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2014-01-23
Effective date
2014-02-24
HHS docket
Docket No. FDA-2013-N-1662
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.