HSA · registration DE0510295

EUROIMMUN Anti-IA2 ELISA (IgG)

Name: EUROIMMUN Anti-IA2 ELISA (IgG) — HSA DE0510295
Creator: EUROIMMUN Medizinische Labordiagnostika AG
Keywords: EUROIMMUN Anti-IA2 ELISA (IgG), EUROIMMUN Anti-IA2 ELISA (IgG), DE0510295, Immunology, HSA

SingaporeImmunologyClass BEUROIMMUN Medizinische Labordiagnostika AG

Verified

Official record identity

Registration number: DE0510295
Model name: Anti-IA2 ELISA (IgG)
Model identifier: EA 1023-9601 G
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 ELISA test kit provides a quantitative in vitro assay for human autoantibodies against tyrosine phosphatase (IA2) in serum or plasma for the diagnosis of Type 1 diabetes mellitus (insulin-dependent diabetes mellitus, IDDM).

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.