HSA · registration DE0015987

ORGENTEC Diagnostika Alegria Anti-Annexin V IgM Test strip

Name: ORGENTEC Diagnostika Alegria Anti-Annexin V IgM Test strip — HSA DE0015987
Creator: ORGENTEC Diagnostika GmbH
Keywords: ORGENTEC Diagnostika Alegria Anti-Annexin V IgM Test strip, ORGENTEC Diagnostika Alegria Anti-Annexin V IgM Test strip, DE0015987, Immunology, HSA

SingaporeImmunologyClass BORGENTEC Diagnostika GmbH

Verified

Official record identity

Registration number: DE0015987
Model name: Anti-Annexin V IgM; ALEGRIA; Positive Control; Negative Control
Model identifier: ORG 243M-24; ORG 300-00; ORG 310; ORG 311
Registration date: July 15, 2014
Source update date: May 19, 2026

Classification

Risk class: Class B
Published category: Immunology

Published parties

Product owner: ORGENTEC Diagnostika GmbH
Registrant / registration holder: SEBIA SINGAPORE PTE. LTD.

Official description

Anti-Annexin V IgM is an ELISA-based test system for the quantitative measurement of IgM class autoantibodies against annexin V in human serum or plasma samples. This product is intended for professional in vitro diagnostic use only.

Additional source fields

Product owner address: Carl-Zeiss-Strasse 49-51, 55129 Mainz, Mainz, Rheinland-Pfalz, Germany
Registrant address: 51 CHANGI BUSINESS PARK CENTRAL 2, #09-12, THE SIGNATURE, Singapore 486066

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.