| Device |
auto-antibodies; phosphatidylserine, prothrombin, phosphatidylserine/prothrombin complex |
| Regulation Description |
Multiple autoantibodies immunological test system. |
| Definition |
For the detection of autoantibodies to phosphatidylserine (ps), prothrombin (pt), or phosphatidylserine/prothrombin (ps/pt) complex in human serum or plasma.To aid in the diagnosis of certain autoimmune thrombotic disorders such as anti-phospholipid syndrome and those secondary to systemic lupus erythematosus or other lupus-like diseases. |
| Physical State |
Microtiter plate coated with purified antigen, enzyme labelled anti-human antibody substrate |
| Technical Method |
ELISA |
| Target Area |
peripheral blood samples |
| Regulation Medical Specialty |
Immunology |
| Review Panel |
Immunology |
|---|
| Product Code | OPN |
|---|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
866.5660
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
| Third Party Review |
Not Third Party Eligible |
|
|
