GNC · Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp.
Microbiology · 21 CFR 866.3550 · Class 2
Overview
| Product Code | GNC |
|---|---|
| Device Name | Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. |
| Regulation | 21 CFR 866.3550 |
| Device Class | Class 2 |
| Review Panel | Microbiology |
Identification
Salmonella spp. serological reagents are devices that consist of antigens and antisera used in serological tests to identify Salmonella spp. from cultured isolates derived from clinical specimens. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify Salmonella spp. directly from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of salmonellosis caused by bacteria belonging to the genus Salmonella and provides epidemiological information on this disease. Salmonellosis is characterized by high grade fever (“enteric fever”), severe diarrhea, and cramps.
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 (20 of 60)
Showing 20 most recent of 60 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K972395 | VISTA ANTIGEN SALMONELLA O GROUP D | Lee Laboratories, Inc. | Aug 25, 1997 | SESE |
| K972392 | VISTA ANTIGEN SALMONELLA H A | Lee Laboratories, Inc. | Aug 25, 1997 | SESE |
| K972391 | VISTA ANTIGEN SALMONELLA H B | Lee Laboratories, Inc. | Aug 25, 1997 | SESE |
| K972390 | VISTA ANTIGEN SALMONELLA H C | Lee Laboratories, Inc. | Aug 25, 1997 | SESE |
| K972389 | VISTA ANTIGEN SALMONELLA H D | Lee Laboratories, Inc. | Aug 25, 1997 | SESE |
| K972388 | VISTA ANTIGEN SALMONELLA O GROUP C | Lee Laboratories, Inc. | Aug 25, 1997 | SESE |
| K972387 | VISTA ANTIGEN SALMONELLA O GROUP A | Lee Laboratories, Inc. | Aug 25, 1997 | SESE |
| K972386 | VISTA ANTIGEN SALMONELLA O GROUP B | Lee Laboratories, Inc. | Aug 25, 1997 | SESE |
| K955228 | SAS SPICER-EDWARDS L COMPLEX | Sa Scientific, Inc. | Feb 13, 1996 | SESE |
| K955227 | SAS SPICER-EDWARDS EN COMPLEX ANTISERUM | Sa Scientific, Inc. | Feb 13, 1996 | SESE |
| K955226 | SAS SPICER-EDWARDS 4 ANTISERUM | Sa Scientific, Inc. | Feb 13, 1996 | SESE |
| K955225 | SAS SPICER-EDWARDS 3 ANTISERUM | Sa Scientific, Inc. | Feb 13, 1996 | SESE |
| K955224 | SAS SPICER-EDWARDS 2 ANTISERUM | Sa Scientific, Inc. | Feb 13, 1996 | SESE |
| K955223 | SAS SPICER-EDWARDS 1 ANTISERUM | Sa Scientific, Inc. | Feb 13, 1996 | SESE |
| K955221 | SAS SALMONELLA H Z38 ANTISERUM | Sa Scientific, Inc. | Feb 7, 1996 | SESE |
| K955220 | SAS SALMONELLA H Z36 ANTISERUM | Sa Scientific, Inc. | Feb 7, 1996 | SESE |
| K955219 | SAS SALMONELLA H FACTOR 7 ANTISERUM | Sa Scientific, Inc. | Feb 7, 1996 | SESE |
| K955218 | SAS SALMONELLA H 1,7 ANTISERUM | Sa Scientific, Inc. | Feb 7, 1996 | SESE |
| K955217 | SAS SALMONELLA H 1,2 ANTISERUM | Sa Scientific, Inc. | Feb 7, 1996 | SESE |
| K955216 | SAS SALMONELLA H A ANTISERUM | Sa Scientific, Inc. | Feb 7, 1996 | SESE |
Top Applicants
- Sa Scientific, Inc. — 49 clearances
- Lee Laboratories, Inc. — 8 clearances
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 1 clearance
- Immunostics Co., Inc. — 1 clearance
- Volu Sol Medical Industries — 1 clearance
