Singapore HSA registration DE0506253
Siemens Atellica IM HBc Total 2 (HBcT2)
Singapore·CLASS D IVD·Siemens Healthcare Diagnostics Products Limited·Registered October 04, 2021Device classification
- Device Class
- CLASS D IVD
- Medical Speciality Area
- Immunology
Registration information
- Registration Number
- DE0506253
- Registration Date
- October 04, 2021
- Change Notification Approval Date
- June 04, 2024
- Retention Due Date
- October 03, 2025
Product description
The Atellica® IM 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 Atellica® IM Analyzer. 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
- Gly 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)
- Atellica IM 1600 Analyzer Atellica IM 1300 Analyzer Atellica Direct Load Atellica Sample Handler (SH) Atellica Sample Handler Additional (SH Additional) Atellica IM Acid/Base Atellica IM Wash Atellica IM Cleaner Atellica IM HBc Total 2 (HBcT2) Atellica IM HBcT2 QC Atellica IM Acid Atellica IM Base
- Model Identifier(s)
- 11066000 11066001 11068008 11069001 11069004 11098500 11098501 11098502 11200739 11200740 11417929 11417930
About this record
Access comprehensive regulatory information for Siemens Atellica IM 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 DE0506253 and owned by Siemens Healthcare Diagnostics Products Limited. The device was registered on October 04, 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