| Device |
group a streptococcus nucleic acid amplification assay system |
| Regulation Description |
Streptococcusspp. serological reagents. |
| Definition |
An in vitro diagnostic test for the detection of streptococcuc pyogenes (group a beta hemolytic streptococcus) in throat swab specimens from symptomatic patients. |
| Physical State |
May include automated/manual isothermal nucleic acid amplification, polymerase chain reaction, ligase chain reaction, sequence-based amplification |
| Technical Method |
Uses nucleic acid amplification technology to detect Group A Sreptococci |
| Target Area |
Throat Swab Specimen |
| Regulation Medical Specialty |
Microbiology |
| Review Panel |
Microbiology |
|---|
| Product Code | OYZ |
|---|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
866.3740
|
|---|
| Device Class |
1
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
| Third Party Review |
Not Third Party Eligible |
