FITC ANTI-RABIES MONOCLONAL GLOBULIN
Device Facts
| Record ID | K820499 |
|---|---|
| Device Name | FITC ANTI-RABIES MONOCLONAL GLOBULIN |
| Applicant | Centocor, Inc. |
| Product Code | GOI · Microbiology |
| Decision Date | Apr 16, 1982 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.3460 |
| Device Class | Class 2 |
Regulatory Classification
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.
