Singapore HSA registration DE0506079
Siemens Advia Centaur HBc Total 2 (HBcT2)
Singapore·CLASS D IVD·Siemens Healthcare Diagnostics Products Limited·Registered August 16, 2021Device classification
- Device Class
- CLASS D IVD
- Medical Speciality Area
- Immunology
Registration information
- Registration Number
- DE0506079
- Registration Date
- August 16, 2021
- Change Notification Approval Date
- October 16, 2024
- Retention Due Date
- August 15, 2025
Product description
The ADVIA Centaur® HBc Total 2 (HBcT2) assay is for in vitro diagnostic use in the qualitative determination of total antibodies to the core antigen of the hepatitis B virus (HBV) in human serum or plasma using the ADVIA CP, ADVIA Centaur XP and ADVIA Centaur XPT systems. This assay can be used as an aid in the diagnosis of individuals (neonates, children, adolescents, and adults) with acute or chronic hepatitis B virus (HBV) infection, and in the determination of the clinical status of HBV-infected individuals in conjunction with other HBV serological markers for the laboratory diagnosis of HBV disease associated with HBV infection. This assay can also be used as an aid in the differential diagnosis in individuals displaying signs and symptoms of hepatitis in whom etiology is unknown.
Product Owner
- Short Name
- Siemens Healthcare Diagnostics Products Limited
- Address
- Glyn Rhonwy, Llanberis, Gwynedd LL55 4EL, UNITED KINGDOM
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)
- ADVIA Centaur Wash 1 ADVIA Centaur Probe Wash 3 ADVIA Centaur Ancillary Probe Wash 1 ADVIA Centaur Wash 1 ADVIA Centaur XP System Sample Cups (1500) Cuvettes (3000) Sample Tips Kit (6480) ADVIA Centaur CP System ADVIA Centaur Acid/Base Reagent ADVIA Centaur Cleaning Solution Concentrate ADVIA Centaur® HBc Total 2 (HBcT2) ADVIA Centaur HBc Total 2 (HBcT2) QC ADVIA Centaur XPT System
- Model Identifier(s)
- 01137199 (112351) 3333963 3395373 3773025 078-A011-03 078-K137-01 078-K138-01 078-K139-01 086-A002-01 10310026 (112219) 10310041 (112748) 10376698 10376699 10711433
About this record
Access comprehensive regulatory information for Siemens Advia Centaur HBc Total 2 (HBcT2) in the Singapore medical device market through Pure Global AI's free database. This CLASS D IVD medical device is registered under HSA registration number DE0506079 and owned by Siemens Healthcare Diagnostics Products Limited. The device was registered on August 16, 2021.
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 D IVD