Device |
group a streptococcus nucleic acid amplification assay system |
Definition |
An in vitro diagnostic test for the detection of Streptococcuc pyogenes (Group A beta hemolytic Streptococcus) in throat swab specimens from symptomatic patients. |
Product Code | OYZ |
Regulation Number |
866.3740
|
Device Class |
1
|
|
|