GTP · Exoenzymes, Multiple, Streptococcal
Microbiology · 21 CFR 866.3720 · Class 1
Overview
| Product Code | GTP |
|---|---|
| Device Name | Exoenzymes, Multiple, Streptococcal |
| Regulation | 21 CFR 866.3720 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
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.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K860041 | STREP D FLUOR | Bio Spec, Inc. | Jan 24, 1986 | SESE |
| K833738 | LEAP STREP TEST KIT | Cooper Biomedical, Inc. | Dec 27, 1983 | SESE |
| K822799 | STREPTACOCCUS CO-AGGLUTINATION KIT | American Scientific Products | Dec 19, 1982 | SESE |
Top Applicants
- American Scientific Products — 1 clearance
- Bio Spec, Inc. — 1 clearance
- Cooper Biomedical, Inc. — 1 clearance
