Medical Device Division · registration 210446ActiveSiemens
Hong KongIVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Core AntibodyIVD Class DSiemens Healthcare Diagnostics Products Limited
Official record identity
- MDACS listing number
- 210446
- Model name
- Atellica IM HBc Total 2 (HBcT2) (11200739), Advia Centaur HBc Total 2 (HBcT2) (10376698), Atellica IM HBc Total 2 Quality Control (HBcT2 QC) (11200740), Advia Centaur HBc Total 2 (HBcT2) Quality Control (10376699)
- Registration date
- August 05, 2026
- Expiry date
- January 16, 2032
- Source update date
- August 10, 2026
- Status
- Active
Official value: Valid
Classification
- Risk class
- IVD Class D
- Published category
- IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Core Antibody
Official value: D
Published parties
- Registrant / registration holder
- Siemens Healthcare Limited
- Manufacturer
- Siemens Healthcare Diagnostics Products Limited
Official description
IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Core Antibody
Additional source fields
- AMD nomenclature code
- 17355
- Traditional Chinese local responsible person
- 西門子醫療有限公司
- Local responsible person phone
- 25833388
- Published manufacturer address
- Glyn Rhonwy, Llanberis, Gwynedd, LL55, 4EL, United Kingdom
- Revision number
- a
About this record
This page mirrors one official MDACS listing. Roman-numeral classes use Hong Kong’s general medical-device scheme, while letter classes use the IVD scheme. Valid, expired, and delisted records remain distinguishable; no mixed classification scale is fabricated.