Singapore HSA registration DE0011445
Siemens ADVIA Chemistry 1800, 2400, XPT Immunoglobulin A_2 (IGA_2)
Singapore·CLASS B IVD·Simens Healthcare Diagnostics Inc.·Registered October 24, 2012Device 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 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 body’s inability to resist infectious agents.
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)
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B IVD