Medical Device Division · registration 100358CancelledSiemens
Hong KongReagents, Serology, Virus, Hepatitis B, Core AntibodyIVD Class DSiemens Healthcare Diagnostics Products Limited
Official record identity
- MDACS listing number
- 100358
- Model name
- IMMULITE/IMMULITE 1000 Anti-HBc (LKHC1, LKHC5, LSUBX, LPWS2, LKPM)
- Registration date
- October 22, 2010
- Source update date
- July 15, 2025
- Status
- Cancelled
Official value: Delisted
Classification
- Risk class
- IVD Class D
- Published category
- Reagents, Serology, Virus, Hepatitis B, Core Antibody
Official value: D
Published parties
- Registrant / registration holder
- Siemens Healthcare Diagnostics 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
- 西門子醫療診斷設備有限公司
- Local responsible person phone
- 25833388
- Published manufacturer address
- Glyn Rhonwy, Llanberis, Gwynedd LL55 4EL, United Kingdom.
- Published remarks
- Delisted.
- Delist date
- 2013-11-12
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.