Medical Device Division · registration 130369CancelledSiemens
Hong KongIVD Test Reagent/Kits, Serology, Virus, Hepatitis BIVD Class DSiemens Healthcare Diagnostics Products Limited
Official record identity
- MDACS listing number
- 130369
- Model name
- IMMULITE / IMMULITE 1000 Anti-HBs (LKAH), IMMULITE / IMMULITE 1000 Anti-HBc (LKHC), IMMULITE / IMMULITE 1000 HBsAg (LKHB), IMMULITE / IMMULITE 1000 Anti-HBc IgM (LKMC), IMMULITE / IMMULITE 1000 Chemiluminescent (LSUBX), IMMULITE / IMMULITE 1000 Probe Wash Module (LPWS2), IMMULITE / IMMULITE 1000 Probe Cleaning Kit (LKPM)
- Registration date
- February 17, 2016
- Source update date
- July 15, 2025
- Status
- Cancelled
Official value: Delisted
Classification
- Risk class
- IVD Class D
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
Additional source fields
- AMD nomenclature code
- 19407
- 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
- Published remarks
- Delisted.
- Revision number
- a
- Delist date
- 2018-10-26
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.