GOI · Antiserum, Fluorescent, Rabies Virus
Microbiology · 21 CFR 866.3460 · Class 2
Overview
| Product Code | GOI |
|---|---|
| Device Name | Antiserum, Fluorescent, Rabies Virus |
| Regulation | 21 CFR 866.3460 |
| Device Class | Class 2 |
| Review Panel | Microbiology |
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).
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K972975 | LIGHT DIAGNOSTICS RABIES DFA REAGENT | Light Diagnostics | Dec 22, 1998 | SESE |
| K820499 | FITC ANTI-RABIES MONOCLONAL GLOBULIN | Centocor, Inc. | Apr 16, 1982 | SESE |
Top Applicants
- Centocor, Inc. — 1 clearance
- Light Diagnostics — 1 clearance
