PHF
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Zinc Transporter 8 Auto-Antibody
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5670
- Medical specialty
- Immunology
- Flags
- Third-party review eligible
- FDA 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 Zinc Transporter 8 Autoantibody (ZnT8Ab) ELISA Assay may be useful as an aid in the diagnosis of Type 1 diabetes mellitus (autoimmune mediated diabetes). The ZnT8Ab assay is not to be used alone and is to be used in conjunction with other clinical and laboratory findings.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| ZINC TRANSPORTER 8 ANTIBODY (ZNT8AB) ELISA ASSAY KIT (DEN140001) | Kronus Market Development Associates, Inc. | 2014-08-20 |
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