GTX · Antisera, Fluorescent, All Groups, Streptococcus Spp.
Microbiology · 21 CFR 866.3740 · Class 1
Overview
| Product Code | GTX |
|---|---|
| Device Name | Antisera, Fluorescent, All Groups, Streptococcus Spp. |
| Regulation | 21 CFR 866.3740 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
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.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K812013 | FLUORESCENT ANTIBODY CONJUGATE FOR GP.A | Springwood Microbiologicals | Jul 28, 1981 | SESE |
| K801876 | STREP B POLYVALENT FLUORO-KIT | Clinical Sciences, Inc. | Sep 16, 1980 | SESE |
Top Applicants
- Clinical Sciences, Inc. — 1 clearance
- Springwood Microbiologicals — 1 clearance
