MODIFICATION TO BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST
Device Facts
| Record ID | K010523 |
|---|---|
| Device Name | MODIFICATION TO BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST |
| Applicant | Binax, Inc. |
| Product Code | GTZ · Microbiology |
| Decision Date | Mar 15, 2001 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 866.3740 |
| Device Class | Class 1 |
Regulatory Classification
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.
