HSA · registration DE0015989

ORGENTEC Diagnostika Alegria Anti-HSV IgM Abs. Test Strip

Name: ORGENTEC Diagnostika Alegria Anti-HSV IgM Abs. Test Strip — HSA DE0015989
Creator: ORGENTEC Diagnostika GmbH
Keywords: ORGENTEC Diagnostika Alegria Anti-HSV IgM Abs. Test Strip, ORGENTEC Diagnostika Alegria Anti-HSV IgM Abs. Test Strip, DE0015989, Immunology, HSA

SingaporeImmunologyClass CORGENTEC Diagnostika GmbH

Verified

Official record identity

Registration number: DE0015989
Model name: ALEGRIA; Positive Control; Negative Control; Anti-HSV-1 IgM Abs.; Anti-HSV-2 IgM Abs.; Anti-HSV-1/2 IgM Abs.
Model identifier: ORG 300-00; ORG 310; ORG 311; ORG 903MX; ORG 904MX; ORG 905MX
Registration date: July 16, 2014
Source update date: May 19, 2026

Classification

Risk class: Class C
Published category: Immunology

Published parties

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

Official description

An ELISA-based test system for the quantitative measurement of IgM class antibodies against Herpes simplex Virus 1 and 2 in human serum or plasma samples. This product is intended for professional in vitro diagnostic use only. The Alegria® Anti-HSV-1/2 IgM Abs. offers test strips with integrated rheumatoid factor (RF) absorbent.

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.