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Siemens ADVIA Chemistry 1800, 2400, XPT Immunoglobulin A_2 (IGA_2) - HSA Registration DE0011445

Access comprehensive regulatory information for Siemens ADVIA Chemistry 1800, 2400, XPT Immunoglobulin A_2 (IGA_2) in the Singapore medical device market through Pure Global AI's free database. This CLASS B IVD medical device is registered under HSA registration number DE0011445 and owned by Simens Healthcare Diagnostics Inc.. The device was registered on October 24, 2012.

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.

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CLASS B IVD
DE0011445
Siemens ADVIA Chemistry 1800, 2400, XPT Immunoglobulin A_2 (IGA_2)
HSA Registration Number: DE0011445
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Product Description

For in vitro diagnostic use in the quantitative determination of immunoglobulin A (IgA) in human serum and plasma on the ADVIA Chemistry systems. Such measurements are used to aid in the diagnosis of abnormal protein metabolism and the bodyโ€™s inability to resist infectious agents.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Immunology
Registration Information
Registration Number
DE0011445
Registration Date
October 24, 2012
Change Notification Approval Date
August 23, 2018
Retention Due Date
October 23, 2025
Product Owner
Short Name
Siemens Health
Address
511 Benedict Avenue, Tarrytown, New York 10591-5097, New York, UNITED STATES
Registrant
Address
60 MACPHERSON ROAD, THE SIEMENS CENTRE, SINGAPORE 348615
Importer
Address
60 MACPHERSON ROAD, THE SIEMENS CENTRE, SINGAPORE 348615
Model Information
Model Name(s)
Immunoglobulin A_2 Reagents Liquid Specific Protein Calibrators
Model Identifier(s)
02194102 07711199 (B03-4845-01)