Antigens (Febrile), Agglutination, Brucella Spp.
The Antigens (Febrile), Agglutination, Brucella Spp. consists of febrile agglutination antigens derived from Brucella species used in tube or slide agglutination tests to detect and titer anti-Brucella antibodies in patient serum, aiding in the diagnosis of brucellosis. As an FDA Class 2 device, it carries moderate risk and requires 510(k) premarket clearance. The product code is GSO, regulated under 21 CFR 866.3085 in the Microbiology specialty. No special flags apply to this device.
Basic Information
- Product Code
- GSO
- Device Class
- FDA class 2
- Regulation Number
- 866.3085
- 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 12 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K972396 | VISTA ANTIGEN BRUCELLA MELITENSIS | Aug 25, 1997 | Substantially Equivalent | Lee Laboratories, Inc. |
| K972394 | VISTA ANTIGEN BRUCELLA ABORTUS | Aug 25, 1997 | Substantially Equivalent | Lee Laboratories, Inc. |
| K952139 | SAS BRUCELLA SUIS ANTIGEN | Jul 18, 1995 | Substantially Equivalent | Sa Scientific, Inc. |
| K952147 | SAS BRUCELLA ABORTUS ANTIGEN | Jul 17, 1995 | Substantially Equivalent | Sa Scientific, Inc. |
| K952140 | SAS BRUCELLA MELTIENSIS ANTIGEN | Jul 17, 1995 | Substantially Equivalent | Sa Scientific, Inc. |
| K952137 | SAS SALMONELLA H A ANTIGEN | Jul 17, 1995 | Substantially Equivalent | Sa Scientific, Inc. |
| K952136 | SAS SALMONELLA H B ANTIGEN | Jul 17, 1995 | Substantially Equivalent | Sa Scientific, Inc. |
| K952135 | SAS SALMONELLA H D ANTIGEN | Jul 17, 1995 | Substantially Equivalent | Sa Scientific, Inc. |
| K952131 | SAS FEBRILE ANTIGEN SET | Jul 17, 1995 | Substantially Equivalent | Sa Scientific, Inc. |
| K885112 | BRUCELLA IFA* | Aug 15, 1989 | Substantially Equivalent | Investigacion Farmaceutica S.A. DE C.V. |
| K822663 | FEBRILE ANTIGEN KIT | Sep 21, 1982 | Substantially Equivalent | Oxoid U.S.A., Inc. |
| K791449 | AGGLUTINOTEST-BRUCELLA | Sep 24, 1979 | Substantially Equivalent | Volu Sol Medical Industries |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.