HSA · registration DE0510294

EUROIMMUN Anti-Zinc Transporter 8 ELISA

Name: EUROIMMUN Anti-Zinc Transporter 8 ELISA — HSA DE0510294
Creator: EUROIMMUN Medizinische Labordiagnostika AG
Keywords: EUROIMMUN Anti-Zinc Transporter 8 ELISA, EUROIMMUN Anti-Zinc Transporter 8 ELISA, DE0510294, Immunology, HSA

SingaporeImmunologyClass BEUROIMMUN Medizinische Labordiagnostika AG

Verified

Official record identity

Registration number: DE0510294
Model name: Anti-Zinc Transporter 8 ELISA
Model identifier: EA 1027-9601
Registration date: January 31, 2025

Classification

Risk class: Class B
Published category: Immunology

Published parties

Product owner: EUROIMMUN Medizinische Labordiagnostika AG
Registrant / registration holder: EUROIMMUN (SOUTH EAST ASIA) PTE. LTD.

Official description

The enzyme immunoassay (ELISA) provides quantitative in vitro determination of human autoantibodies against zinc transporter 8 (ZnT8) in serum or plasma to support the diagnosis of type 1 diabetes mellitus (insulin-dependent diabetes mellitus, IDDM). The product is designed for use as IVD.

Additional source fields

Product owner address: Seekamp 31, 23560 Lübeck, Germany
Registrant address: 438A ALEXANDRA ROAD, #02-05/10, ALEXANDRA TECHNOPARK, Singapore 119967

About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.