SAS SHIGELLA BOYDII TYPE 8 ANTISERUM
Device Facts
| Record ID | K961541 |
|---|---|
| Device Name | SAS SHIGELLA BOYDII TYPE 8 ANTISERUM |
| Applicant | Sa Scientific, Inc. |
| Product Code | GNB · Microbiology |
| Decision Date | May 20, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.3660 |
| Device Class | Class 2 |
Regulatory Classification
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.
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.
