Medical Device Division · registration 130375CancelledSiemens
Hong KongIVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Core AntibodyIVD Class DSiemens Healthcare Diagnostics Products Limited
Official record identity
- MDACS listing number
- 130375
- Model name
- IMMULITE 2000 Anti-HBc (L2KHC2, L2KHC6, L2SUBM, L2PWSM, L2KPM)
- Registration date
- October 16, 2013
- Source update date
- July 15, 2025
- Status
- Cancelled
Official value: Delisted
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 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
- 2015-11-20
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.