21 CFR 866.3460 — Antiserum, Fluorescent, Rabies Virus

Microbiology (MI) · Part 866 Subpart D—Serological Reagents · § 866.3460

Identification

Rabiesvirus immunofluorescent reagents are devices that consist of rabiesvirus antisera conjugated with a fluorescent dye used to identify rabiesvirus in specimens taken from suspected rabid animals. The identification aids in the diagnosis of rabies in patients exposed by animal bites and provides epidemiological information on rabies. Rabies is an acute infectious disease of the central nervous system which, if undiagnosed, may be fatal. The disease is commonly transmitted to humans by a bite from a rabid animal.

Classification Rationale

Class II (performance standards).

Product Codes