Zinc Transporter 8 Auto-Antibody
- US Product Code (FDA)
- PHFView Product Code Classification →
- US Risk Class (FDA)
- Class 2
- US Regulation (CFR)
- 21 CFR 866.5670View CFR Regulation →
- Medical specialty
- Immunology
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Eligible
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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Zinc Transporter 8 Auto-Antibody is a medical device type in the Immunology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.
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