HSA · registration DE0506079Siemens Advia Centaur HBc Total 2 (HBcT2)
- Registration number
- DE0506079
- Model name
- 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
- 01137199 (112351); 03333963; 03395373; 03773025; 078-A011-03; 078-K137-01; 078-K138-01; 078-K139-01; 086-A002-01; 10310026 (112219); 10310041 (112748); 10376698; 10376699; 10711433
- Registration date
- August 16, 2021
- Source update date
- June 24, 2022
- Risk class
- Class D
- Product owner
- Siemens Healthcare Diagnostics Products Limited
- Registrant / registration holder
- SIEMENS HEALTHCARE PTE. LTD.
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 address
- Glyn Rhonwy, Llanberis, Gwynedd LL55 4EL, United Kingdom
- Registrant address
- 60 MACPHERSON ROAD, THE SIEMENS CENTRE, Singapore 348615
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.