LEAP STREP TEST KIT
Device Facts
| Record ID | K833738 |
|---|---|
| Device Name | LEAP STREP TEST KIT |
| Applicant | Cooper Biomedical, Inc. |
| Product Code | GTP · Microbiology |
| Decision Date | Dec 27, 1983 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.3720 |
| Device Class | Class 1 |
Regulatory Classification
Identification
Streptococcus spp. exoenzyme reagents are devices used to identify antibodies to Streptococcus spp. exoenzyme in serum. The identification aids in the diagnosis of disease caused by bacteria belonging to the genus Streptococcus and provides epidemiological information on these diseases. Pathogenic streptococci are associated with infections, such as sore throat, impetigo (an infection characterized by small pustules on the skin), urinary tract infections, rheumatic fever, and kidney disease.
