FEBRILE ANTIGENS & CONTROL SERUMS
Device Facts
| Record ID | K760097 |
|---|---|
| Device Name | FEBRILE ANTIGENS & CONTROL SERUMS |
| Applicant | Gamma Biologicals, Inc. |
| Product Code | GSZ · Microbiology |
| Decision Date | Aug 3, 1976 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.3410 |
| Device Class | Class 1 |
Regulatory Classification
Identification
Proteus spp. (Weil-Felix) serological reagents are devices that consist of antigens and antisera, including antisera conjugated with a fluorescent dye (immunofluorescent reagents), derived from the bacterium Proteus vulgaris used in agglutination tests (a specific type of antigen-antibody reaction) for the detection of antibodies to rickettsia (virus-like bacteria) in serum. Test results aid in the diagnosis of diseases caused by bacteria belonging to the genus Rickettsiae and provide epidemiological information on these diseases. Rickettsia are generally transmitted by arthropods (e.g., ticks and mosquitoes) and produce infections in humans characterized by rash and fever (e.g., typhus fever, spotted fever, Q fever, and trench fever).
