Pure Global AI
FDA product code PHF

Zinc Transporter 8 Auto-Antibody

ImmunologyClass 221 CFR 866.5670
Verified
US regulatory classifications
US Product Code (FDA)
PHF
View Product Code Classification
US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 866.5670
View CFR Regulation
Medical specialty
Immunology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Eligible
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.

Search keywords

Click to search for similar devices in our global database

01ZnT8 antibody02Autoantibody test03Diabetes test04Autoimmune test05Type 1 diabetes06Antibody assay07Diagnostic test08Immunology09Lab test10Islet antibody
About this record

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.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.