Antigens, Febrile (Weil-Felix), All Groups
The Antigens, Febrile (Weil-Felix), All Groups is a set of Proteus-based febrile antigens used in the Weil-Felix agglutination test, a historical serological method for the presumptive diagnosis of rickettsial diseases based on cross-reactive antibodies. It is an FDA Class 1 device, requiring only general controls and no premarket submission. Regulated under 21 CFR 866.3410 with product code GSZ in the Microbiology specialty. No special flags apply to this device.
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Basic Information
- Product Code
- GSZ
- Device Class
- FDA class 1
- Regulation Number
- 866.3410
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K885110 | PROTEUS OX-19 IFA* | Aug 15, 1989 | Substantially Equivalent | Investigacion Farmaceutica S.A. DE C.V. |
| K760881 | FEBRILE ANTIGEN CONTROL SERA | Nov 09, 1976 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K760097 | FEBRILE ANTIGENS & CONTROL SERUMS | Aug 03, 1976 | Substantially Equivalent | Gamma Biologicals, Inc. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.