HSA · registration DE0015965

ORGENTEC Diagnostika Alegria Anti-Annexin V IgG/IgM

Name: ORGENTEC Diagnostika Alegria Anti-Annexin V IgG/IgM — HSA DE0015965
Creator: ORGENTEC Diagnostika GmbH
Keywords: ORGENTEC Diagnostika Alegria Anti-Annexin V IgG/IgM, ORGENTEC Diagnostika Alegria Anti-Annexin V IgG/IgM, DE0015965, Immunology, HSA

SingaporeImmunologyClass BORGENTEC Diagnostika GmbH

Verified

Official record identity

Registration number: DE0015965
Model name: Anti-Annexin V IgG/IgM
Model identifier: ORG 643
Registration date: July 14, 2014

Classification

Risk class: Class B
Published category: Immunology

Published parties

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

Official description

Anti-Annexin V IgG/IgM is an indirect solid phase enzyme immunoassay (ELISA) for the quantitative measurement of IgG and IgM class autoantibodies against Annexin V in human serum or plasma. The assay is intended for in vitro diagnostic use only as an aid in the diagnosis of an increased risk of thrombosis and recurrent fetal loss.

Additional source fields

Product owner address: Carl-Zeiss-Strasse 49-51, 55129 Mainz, Mainz, Rheinland-Pfalz, Germany
Registrant address: 627A ALJUNIED ROAD, #08-09, BIZTECH CENTRE, Singapore 389842

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.