Definition: The Zinc Transporter 8 Autoantibody (ZnT8Ab) ELISA Assay Is For The Semi-quantitative Determination Of Autoantibodies To Zinc Transporter 8 (ZnT8) In Human Serum. The KRONUS Zinc Transporter 8 Autoantibody (ZnT8Ab) ELISA Assay May Be Useful As An Aid
| Device Type ID | 3103 |
| Device Name | Zinc Transporter 8 Auto-antibody |
| Physical State | Assay Kit Includes Strip Wells Coated With ZnT8; 4 Level Calibrators; Positive And Negative Controls; Zinc Biotin; Buffer; Streptavidin Peroxide; Diluent; Peroxide Substrate; Wash Solution; Stop Solution |
| Technical Method | ELISA Assay |
| Target Area | Serum (blood) Sample |
| Regulation Description | Zinc Transporter 8 Autoantibody 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 | 866.5670 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PHF |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3103 |
| Device | Zinc Transporter 8 Auto-antibody |
| Product Code | PHF |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Zinc Transporter 8 Autoantibody Immunological Test System. |
| CFR Regulation Number | 866.5670 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
KRONUS MARKET DEVELOPMENT ASSOCIATES, INC. | ||
GRANTED | 1 | |