GSO · Antigens (Febrile), Agglutination, Brucella Spp.
Microbiology · 21 CFR 866.3085 · Class 2
Overview
| Product Code | GSO |
|---|---|
| Device Name | Antigens (Febrile), Agglutination, Brucella Spp. |
| Regulation | 21 CFR 866.3085 |
| Device Class | Class 2 |
| Review Panel | Microbiology |
Identification
Brucella spp. serological reagents are devices that consist of antigens and antisera used for serological identification of Brucella spp. from cultured isolates derived from clinical specimens or to identify antibodies to Brucella spp. in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify Brucella spp. directly from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of brucellosis (e.g., undulant fever, Malta fever) caused by bacteria belonging to the genus Brucella and provides epidemiological information on diseases caused by these microorganisms.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
Recent Cleared Devices (12 of 12)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K972396 | VISTA ANTIGEN BRUCELLA MELITENSIS | Lee Laboratories, Inc. | Aug 25, 1997 | SESE |
| K972394 | VISTA ANTIGEN BRUCELLA ABORTUS | Lee Laboratories, Inc. | Aug 25, 1997 | SESE |
| K952139 | SAS BRUCELLA SUIS ANTIGEN | Sa Scientific, Inc. | Jul 18, 1995 | SESE |
| K952147 | SAS BRUCELLA ABORTUS ANTIGEN | Sa Scientific, Inc. | Jul 17, 1995 | SESE |
| K952140 | SAS BRUCELLA MELTIENSIS ANTIGEN | Sa Scientific, Inc. | Jul 17, 1995 | SESE |
| K952137 | SAS SALMONELLA H A ANTIGEN | Sa Scientific, Inc. | Jul 17, 1995 | SESE |
| K952136 | SAS SALMONELLA H B ANTIGEN | Sa Scientific, Inc. | Jul 17, 1995 | SESE |
| K952135 | SAS SALMONELLA H D ANTIGEN | Sa Scientific, Inc. | Jul 17, 1995 | SESE |
| K952131 | SAS FEBRILE ANTIGEN SET | Sa Scientific, Inc. | Jul 17, 1995 | SESE |
| K885112 | BRUCELLA IFA* | Investigacion Farmaceutica S.A. DE C.V. | Aug 15, 1989 | SESE |
| K822663 | FEBRILE ANTIGEN KIT | Oxoid U.S.A., Inc. | Sep 21, 1982 | SESE |
| K791449 | AGGLUTINOTEST-BRUCELLA | Volu Sol Medical Industries | Sep 24, 1979 | SESE |
Top Applicants
- Sa Scientific, Inc. — 7 clearances
- Lee Laboratories, Inc. — 2 clearances
- Investigacion Farmaceutica S.A. DE C.V. — 1 clearance
- Oxoid U.S.A., Inc. — 1 clearance
- Volu Sol Medical Industries — 1 clearance
