Device |
gonococcal antibody tests |
Regulation Description |
Gonococcal antibody test (GAT). |
Regulation Medical Specialty |
Microbiology |
Review Panel |
Microbiology |
Product Code | LGB |
Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Microbiology Devices
(DMD)
|
Submission Type |
PMA
|
Regulation Number |
866.3290
|
Device Class |
3
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |
|
|