QUICKVUE IN-LINE ONE STEP STREP A TEST (MODIFICATION)
Device Facts
| Record ID | K954257 |
|---|---|
| Device Name | QUICKVUE IN-LINE ONE STEP STREP A TEST (MODIFICATION) |
| Applicant | Quidel Corp. |
| Product Code | GTZ · Microbiology |
| Decision Date | Oct 20, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| 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.
