GRM · Antisera, All Groups, Salmonella Spp.
Microbiology · 21 CFR 866.3550 · Class 2
Overview
| Product Code | GRM |
|---|---|
| Device Name | Antisera, 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 69)
Showing 20 most recent of 69 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K961967 | SAS SALMONELLA O POLY B ANTISERUM | Sa Scientific, Inc. | Jun 18, 1996 | SESE |
| K961966 | SAS SALMONELLA O GROUP X FACTOR 47 ANTISERUM | Sa Scientific, Inc. | Jun 18, 1996 | SESE |
| K961964 | SAS SALMONELLA O GROUP H FACTORS 14,24,25 ANTISERUM | Sa Scientific, Inc. | Jun 18, 1996 | SESE |
| K961963 | SAS SALMONELLA O GROUP W FACTOR 45 ANTISERUM | Sa Scientific, Inc. | Jun 18, 1996 | SESE |
| K961962 | SAS SALMONELLA O GROUP V FACTOR 44 ANTISERUM | Sa Scientific, Inc. | Jun 18, 1996 | SESE |
| K961961 | SAS SALMONELLA H F,G,T ANTISERUM | Sa Scientific, Inc. | Jun 18, 1996 | SESE |
| K961960 | SAS SALMONELLA H Z4, Z24 ANTISERUM | Sa Scientific, Inc. | Jun 18, 1996 | SESE |
| K961958 | SAS SALMONELLA H Z4 COMPLEX ANTISERUM | Sa Scientific, Inc. | Jun 18, 1996 | SESE |
| K961957 | SAS SALMONELLA H Z4, Z32 ANTISERUM | Sa Scientific, Inc. | Jun 18, 1996 | SESE |
| K961956 | SAS SALMONELLA H G,M,Q ANTISERMU | Sa Scientific, Inc. | Jun 18, 1996 | SESE |
| K961955 | SAS SALMONELLA H Z42 ANTISERUM | Sa Scientific, Inc. | Jun 18, 1996 | SESE |
| K961954 | SAS SALMONELLA H Z35 ANTISERUM | Sa Scientific, Inc. | Jun 18, 1996 | SESE |
| K961953 | SAS SALMONELA H Z24 ANTISERUM | Sa Scientific, Inc. | Jun 18, 1996 | SESE |
| K961952 | SAS SALMONELLA O FACTOR /O GROUP A FACTOR 2 ANTISERUMS | Sa Scientific, Inc. | Jun 18, 1996 | SESE |
| K961951 | SAS SALMONELLA O FACTOR 6 ANTISERUM | Sa Scientific, Inc. | Jun 18, 1996 | SESE |
| K961950 | SAS SALMONELLA O FACTOR 15 ANTISERUM &/OR O GROUP E2 FACTOR 15 ANTISERUM | Sa Scientific, Inc. | Jun 18, 1996 | SESE |
| K961949 | SAS SALMONELLA O FACTOR 14 ANTISERUM | Sa Scientific, Inc. | Jun 18, 1996 | SESE |
| K961948 | SAS SALMONELLA O FACTOR 20 ANTISERUM | Sa Scientific, Inc. | Jun 18, 1996 | SESE |
| K960461 | SAS SALMONELLA O GROUP R FACTOR 40 ANTISERUM | Sa Scientific, Inc. | Mar 12, 1996 | SESE |
| K960160 | SAS SALMONELLA 0 GROUP M FACTOR 28 ANTISERUM | Sa Scientific, Inc. | Mar 12, 1996 | SESE |
Top Applicants
- Sa Scientific, Inc. — 64 clearances
- Ampcor, Inc. — 1 clearance
- Analytical Products, Inc. — 1 clearance
- Armkel, LLC — 1 clearance
- S.M.I. Medical, Inc. — 1 clearance
