GSZ · Antigens, Febrile (Weil-Felix), All Groups
Microbiology · 21 CFR 866.3410 · Class 1
Overview
| Product Code | GSZ |
|---|---|
| Device Name | Antigens, Febrile (Weil-Felix), All Groups |
| Regulation | 21 CFR 866.3410 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
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).
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K885110 | PROTEUS OX-19 IFA* | Investigacion Farmaceutica S.A. DE C.V. | Aug 15, 1989 | SESE |
| K760881 | FEBRILE ANTIGEN CONTROL SERA | Bd Becton Dickinson Vacutainer Systems Preanalytic | Nov 9, 1976 | SESE |
| K760097 | FEBRILE ANTIGENS & CONTROL SERUMS | Gamma Biologicals, Inc. | Aug 3, 1976 | SESE |
Top Applicants
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 1 clearance
- Gamma Biologicals, Inc. — 1 clearance
- Investigacion Farmaceutica S.A. DE C.V. — 1 clearance
