Device |
groups a, c and g beta-hemolytic streptococcus nucleic acid amplification system |
Regulation Description |
Streptococcus spp. nucleic acid-based assay. |
Definition |
An in vitro diagnostic test for the detection of Group A, C and G 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 Groups A, C and G Sreptococci |
Target Area |
Throat swab specimen |
Regulation Medical Specialty |
Microbiology |
Review Panel |
Microbiology |
Product Code | PGX |
Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Microbiology Devices
(DMD)
|
Submission Type |
510(k)
|
Regulation Number |
866.2680
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |