21 CFR 866.3740 — Antisera, Fluorescent, All Groups, Streptococcus Spp.
Microbiology (MI) · Part 866 Subpart D—Serological Reagents · § 866.3740
Identification
Streptococcus spp. serological reagents are devices that consist of antigens and antisera (excluding streptococcal exoenzyme reagents made from enzymes secreted by streptococci) used in serological tests to identify Streptococcus spp. from cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases 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 § 866.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GTX | Antisera, Fluorescent, All Groups, Streptococcus Spp. | 1 | 2 | |
| GTY | Antigens, All Groups, Streptococcus Spp. | 1 | 43 | |
| GTZ | Antisera, All Groups, Streptococcus Spp. | 1 | 105 | |
| GWB | Antisera, Fluorescent, All Types, Streptococcus Pneumoniae | 1 | 2 | |
| GWC | Antisera, All Types, Streptococcus Pneumoniae | 1 | 9 | |
| MCT | Dna-Probe, Strep Pneumoniae | 1 | 1 | |
| MDK | Dna-Probe, Reagents, Streptococcal | 1 | 4 | |
| NJR | Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test | 1 | 18 | |
| OAH | Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis | 1 | 4 | |
| OYZ | Group A Streptococcus Nucleic Acid Amplification Assay System | 1 | 1 |
