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Singapore HSA registration DE0011450

Siemens ADVIA Chemistry 1800, 2400, XPT Rheumatoid Factor (RF)

Singapore flagSingapore·CLASS B IVD·Simens Healthcare Diagnostics Inc.·Registered October 24, 2012
Device classification
Device Class
CLASS B IVD
Medical Speciality Area
Clinical chemistry
Registration information
Registration Number
DE0011450
Registration Date
October 24, 2012
Change Notification Approval Date
August 23, 2018
Retention Due Date
October 23, 2025
Product description
The IVD System is for in vitro diagnostic use in the quantitative determination of rheumatoid factor in human serum on the ADVIA Chemistry systems. Such measurements are used in the diagnosis of rheumatoid arthritis. Rheumatoid factors are auto-antibodies directed against the Fc portion of IgG. The majority of rheumatoid factors are IgM, but may be IgG or IgA. Conditions giving rise to such factors include rheumatic conditions and chronic inflammatory processes.
Product Owner
Name
Simens Healthcare Diagnostics Inc.
Short Name
Siemens Health
Address
511 Benedict Avenue, Tarrytown, New York 10591-5097, New York, UNITED STATES
Registrant
Name
SIEMENS HEALTHCARE PTE. LTD.
Address
60 MACPHERSON ROAD, THE SIEMENS CENTRE, SINGAPORE 348615
Importer
Name
SIEMENS HEALTHCARE PTE. LTD.
Address
60 MACPHERSON ROAD, THE SIEMENS CENTRE, SINGAPORE 348615
Model information
Model Name(s)
ADVIA® Chemistry Rheumatoid Factor (RF) ADVIA Chemistry Liquid Specific Protein Calibrators:
Model Identifier(s)
00655137 (B01-4806-01) 07711199 (PN B03-4845-01)
About this record

Access comprehensive regulatory information for Siemens ADVIA Chemistry 1800, 2400, XPT Rheumatoid Factor (RF) 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 DE0011450 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