Device |
gbs culture media, selective and differential |
Regulation Description |
Selective culture medium. |
Definition |
Culture Medium for GBS Detection |
Physical State |
Media (broth or plates) |
Technical Method |
Chromogenic agar |
Target Area |
not applicable |
Regulation Medical Specialty |
Microbiology |
Review Panel |
Microbiology |
Product Code | PQZ |
Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Microbiology Devices
(DMD)
|
Submission Type |
510(k)
|
Regulation Number |
866.2360
|
Device Class |
1
|
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
|
Accredited Persons
|