Device |
manual blood grouping and antibody test systems |
Regulation Description |
Automated blood grouping and antibody test system. |
Definition |
A manual blood grouping and antibody test system is used to group red blood cells and to detect antibodies to blood group antigens. |
Physical State |
Solid |
Technical Method |
Manual |
Target Area |
IVD |
Regulation Medical Specialty |
Hematology |
Review Panel |
Hematology |
Product Code | PBC |
Premarket Review |
Center for Biologics Evaluation & Research (CBER)
|
Submission Type |
510(k)
|
Regulation Number |
864.9175
|
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 |