SHIGELLA SERA-CHEK
Device Facts
| Record ID | K813191 |
|---|---|
| Device Name | SHIGELLA SERA-CHEK |
| Applicant | Lab Ability, Inc. |
| Product Code | LIA · Microbiology |
| Decision Date | Dec 3, 1981 |
| 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.
