Device |
autoantibodies, skin (bullous pemphigoid 180 and bullous pemphigoid 230 |
Regulation Description |
Multiple autoantibodies immunological test system. |
Definition |
The device is intended as an aid in the diagnosis of bullous pemphigoid. |
Physical State |
n/a |
Technical Method |
ELISA |
Target Area |
n/a |
Regulation Medical Specialty |
Immunology |
Review Panel |
Immunology |
Product Code | OEG |
Premarket Review |
Division of Immunology and Hematology Devices
(DIHD)
Division of Immunology and Hematology Devices
(DIHD)
|
Submission Type |
510(k)
|
Regulation Number |
866.5660
|
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
|