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 Addi
| Device Type ID | 3096 |
| Device Name | 21-hydroxylase Antibody (21-ohab) |
| Physical State | RIA Assay Kit With Reagents, Antigen With I-125, Calibrators, Controls And Assay Buffer. |
| Technical Method | RIA |
| Target Area | None |
| Regulation Description | Multiple Autoantibodies Immunological Test System. |
| Regulation Medical Specialty | Immunology |
| Review Panel | Immunology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 866.5660 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PCG |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3096 |
| Device | 21-hydroxylase Antibody (21-ohab) |
| Product Code | PCG |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Multiple Autoantibodies Immunological Test System. |
| CFR Regulation Number | 866.5660 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
KRONUS MARKET DEVELOPMENT ASSOCIATES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |