ARBOVIRUS IGM IFA TEST
Device Facts
| Record ID | K913618 |
|---|---|
| Device Name | ARBOVIRUS IGM IFA TEST |
| Applicant | Hillcrest Biologicals |
| Product Code | GQC · Microbiology |
| Decision Date | Dec 3, 1992 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.3240 |
| Device Class | Class 1 |
Regulatory Classification
Identification
Equine encephalomyelitis virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antobodies to equine encephalomyelitis virus in serum. The identification aids in the diagnosis of diseases caused by equine encephalomyelitis viruses and provides epidemiological information on these viruses. Equine encephalomyelitis viruses are transmitted to humans by the bite of insects, such as mosquitos and ticks, and may cause encephalitis (inflammation of the brain), rash, acute arthritis, or hepatitis.
