21 CFR 866.3720 — Anti-Streptokinase
Microbiology (MI) · Part 866 Subpart D—Serological Reagents · § 866.3720
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GTO | Anti-Streptokinase | 1 | 0 | |
| GTP | Exoenzymes, Multiple, Streptococcal | 1 | 3 | |
| GTQ | Antistreptolysin - Titer/Streptolysin O Reagent | 1 | 37 | |
| GTR | Antideoxyribonuclease, Streptococcus Spp. | 1 | 1 | |
| LHW | Erythrocyte Suspension, Multi Species, Serological Reagent And Equipment | 1 | 4 |
