| Device |
21-hydroxylase antibody (21-ohab) |
| Regulation Description |
Multiple autoantibodies immunological test system. |
| Definition |
For semi-quantitative determination of antibodies to steroid 21-hydroxylase (21-OH) in human serum. The assay may be useful as an aid in the diagnosis of autoimmune adrenal disease, whether expressed as autoimmune Addison's disease (isolated) or Addison's disease as part of more complex autoimmune polyglandular syndrome (APS), type I or II. The assay result is to be used in conjunction with other clinical and laboratory findings and is not a substitute for functional testing required to diagnose adrenal insufficiency. |
| Physical State |
RIA Assay Kit with reagents, antigen with I-125, calibrators, controls and assay buffer. |
| Technical Method |
RIA |
| Target Area |
None |
| Regulation Medical Specialty |
Immunology |
| Review Panel |
Immunology |
|---|
| Product Code | PCG |
|---|
| 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
|
