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HSA · registration DE0506253

Siemens Atellica IM HBc Total 2 (HBcT2)

SingaporeImmunologyClass DSiemens Healthcare Diagnostics Products Limited
Verified
Official record identity
Registration number
DE0506253
Model name
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
11066000; 11066001; 11068008; 11069001; 11069004; 11098500; 11098501; 11098502; 11200739; 11200740; 11417929; 11417930
Registration date
October 04, 2021
Source update date
June 30, 2023
Classification
Risk class
Class D
Official value: CLASS D
Published category
Immunology
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Published parties
Product owner
Siemens Healthcare Diagnostics Products Limited
Registrant / registration holder
SIEMENS HEALTHCARE PTE. LTD.
Official 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.

Additional source fields
Product owner address
Gly Rhonwy, Llanberis, Gwynedd LL55 4EL, United Kingdom
Registrant address
60 MACPHERSON ROAD, THE SIEMENS CENTRE, Singapore 348615
About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.