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Singapore HSA registration DE0015989

ORGENTEC Diagnostika Alegria Anti-HSV IgM Abs. Test Strip

Singapore flagSingapore·CLASS C IVD·ORGENTEC Diagnostika GmbH·Registered July 16, 2014
Device classification
Device Class
CLASS C IVD
Medical Speciality Area
Immunology
HSA Product Code
HSAMDC00106
HS Code
38220090
Registration information
Registration Number
DE0015989
Registration Date
July 16, 2014
Change Notification Approval Date
October 15, 2024
Retention Due Date
July 15, 2025
Product 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.
Product Owner
Name
ORGENTEC Diagnostika GmbH
Short Name
ORGENTEC Diagnostika GmbH
Address
Carl-Zeiss-Strasse 49-51, 55129 Mainz, Mainz, Rheinland-Pfalz, GERMANY
Registrant
Name
SEBIA SINGAPORE PTE LTD
Address
51 CHANGI BUSINESS PARK CENTRAL 2, THE SIGNATURE, #09-12, SINGAPORE 486066
Importer
Name
SEBIA SINGAPORE PTE LTD
Address
51 CHANGI BUSINESS PARK CENTRAL 2, THE SIGNATURE, #09-12, SINGAPORE 486066
Model information
Model Name(s)
ALEGRIA Positive Control Negative Control Anti-HSV-1 IgM Abs. Anti-HSV-2 IgM Abs. Anti-HSV-1/2 IgM Abs.
Model Identifier(s)
ORG 300-00 ORG 310 ORG 311 ORG 903MX ORG 904MX ORG 905MX
About this record

Access comprehensive regulatory information for ORGENTEC Diagnostika Alegria Anti-HSV IgM Abs. Test Strip in the Singapore medical device market through Pure Global AI's free database. This CLASS C IVD medical device is registered under HSA registration number DE0015989 and owned by ORGENTEC Diagnostika GmbH. The device was registered on July 16, 2014.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS C IVD