Device |
antisera, all groups, n. meningitidis |
Regulation Description |
Neisseria spp. direct serological test reagents. |
Regulation Medical Specialty |
Microbiology |
Review Panel |
Microbiology |
Product Code | GTJ |
Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Microbiology Devices
(DMD)
|
Submission Type |
510(k)
|
Regulation Number |
866.3390
|
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
|
Accredited Persons
|
|
|