GNB · Antisera, All Types, Shigella Spp.
Microbiology · 21 CFR 866.3660 · Class 2
Overview
| Product Code | GNB |
|---|---|
| Device Name | Antisera, All Types, Shigella Spp. |
| Regulation | 21 CFR 866.3660 |
| Device Class | Class 2 |
| Review Panel | Microbiology |
Identification
Shigella spp. serological reagents are devices that consist of antigens and antisera, including antisera conjugated with a fluorescent dye (immunofluorescent reagents), used in serological tests to identify Shigella spp. from cultured isolates. The identification aids in the diagnosis of shigellosis caused by bacteria belonging to the genus Shigella and provides epidemiological information on this disease. Shigellosis is characterized by abdominal pain, cramps, diarrhea, and fever.
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 41)
Showing 20 most recent of 41 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K961537 | SAS SHIGELLA SONNEI FORM II ANTISERUM | Sa Scientific, Inc. | May 31, 1996 | SESE |
| K961559 | SAS SHIGELLA DYSENTERIAE TYPE 9 ANTISERUM | Sa Scientific, Inc. | May 20, 1996 | SESE |
| K961558 | SAS SHIGELLA FLEXNERI TYPE 3 ANTISERUM | Sa Scientific, Inc. | May 20, 1996 | SESE |
| K961556 | SAS SHIGELLA FLEXNERI TYPE 1 ANTISERUM | Sa Scientific, Inc. | May 20, 1996 | SESE |
| K961554 | SAS SHIGELLA BOYDII TYPE 10 ANTISERUM | Sa Scientific, Inc. | May 20, 1996 | SESE |
| K961553 | SAS SHIGELLA DYSENTERIAE TYPE 1 ANTISERUM | Sa Scientific, Inc. | May 20, 1996 | SESE |
| K961551 | SAS SHIGELLA DYSENTERIAE TYPE 2 ANTISERUM | Sa Scientific, Inc. | May 20, 1996 | SESE |
| K961549 | SAS SHIGELLA FLEXNERI TYPE 2 ANTISERUM | Sa Scientific, Inc. | May 20, 1996 | SESE |
| K961548 | SAS SHIGELLA BOYDII TYPE 15 ANTISERUM | Sa Scientific, Inc. | May 20, 1996 | SESE |
| K961547 | SAS SHIGELLA BOYDII TYPE 14 ANTISERUM | Sa Scientific, Inc. | May 20, 1996 | SESE |
| K961546 | SAS SHIGELLA BOYDII GROUP C1/C1 (8-10) ANTISERUM | Sa Scientific, Inc. | May 20, 1996 | SESE |
| K961543 | SAS SHIGELLA BOYDII TYPE 9 ANTISERUM | Sa Scientific, Inc. | May 20, 1996 | SESE |
| K961542 | SAS SHIGELLA FLEXNERI TYPE 4 ANTISERUM | Sa Scientific, Inc. | May 20, 1996 | SESE |
| K961541 | SAS SHIGELLA BOYDII TYPE 8 ANTISERUM | Sa Scientific, Inc. | May 20, 1996 | SESE |
| K961540 | SAS SHIGELLA SONNEI GROUP D ANTISERUM | Sa Scientific, Inc. | May 20, 1996 | SESE |
| K961539 | SAS SHIGELLA DYSENTERIAE TYPE 10 ANTISERUM | Sa Scientific, Inc. | May 20, 1996 | SESE |
| K961538 | SAS SHIGELLA DYSENTERIAE TYPE 8 ANTISERUM | Sa Scientific, Inc. | May 20, 1996 | SESE |
| K961535 | SAS SHIGELLA DYSENTERIAE GROUP A1 (8-10) ANTISERUM | Sa Scientific, Inc. | May 20, 1996 | SESE |
| K961534 | SAS SHIGELLA SONNEI FORM I ANTISERUM (3/100/1000ML) | Sa Scientific, Inc. | May 20, 1996 | SESE |
| K961533 | SAS SHIGELLA FLEXNERI TYPE 6 ANTISERUM | Sa Scientific, Inc. | May 20, 1996 | SESE |
Top Applicants
- Sa Scientific, Inc. — 38 clearances
- Analytical Products, Inc. — 1 clearance
- Pharmacia, Inc. — 1 clearance
- Wellcome Diagnostics — 1 clearance
