| Device |
antibodies, outer-membrane proteins |
| Regulation Description |
Anti-Saccharomyces cerevisiae(S. cerevisiae) antibody (ASCA) test systems. |
| Definition |
For the detection of anti-outer membrane protein (anti-omp) antibodies in human serum.To aid in the diagnosis of crohn's disease. |
| Physical State |
Comprised of antigen coated microtiter plate, enzyme conjugate, substrate, controls |
| Technical Method |
Uses enzyme-linked, immunosorbent assay (ELISA) to identify the presence of anti-OMP antibodies. |
| Target Area |
human serum |
| Regulation Medical Specialty |
Immunology |
| Review Panel |
Immunology |
|---|
| Product Code | OKM |
|---|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
866.5785
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
| Third Party Review |
Not Third Party Eligible |
|
|
