Medical Device Division · registration 190030ExpiredSiemens
Hong KongIVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Surface AntibodyIVD Class DSiemens Healthcare Diagnostics Inc
Official record identity
- MDACS listing number
- 190030
- Model name
- Atellica IM Anti-Hepatitis B surface Antigen 2 (10995453), Atellica IM Anti-Hepatitis B surface Antigen 2 Quality Control (10995454)
- Registration date
- January 24, 2019
- Expiry date
- January 24, 2024
- Source update date
- July 10, 2023
- Status
- Expired
Classification
- Risk class
- IVD Class D
- Published category
- IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Surface Antibody
Official value: D
Published parties
- Registrant / registration holder
- Siemens Healthcare Limited
- Manufacturer
- Siemens Healthcare Diagnostics Inc
Official description
IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Surface Antibody
Additional source fields
- AMD nomenclature code
- 17359
- Traditional Chinese local responsible person
- 西門子醫療有限公司
- Local responsible person phone
- 25833388
- Published manufacturer address
- 511 Benedict Avenue, Tarrytown, New York 10591, USA
- Published remarks
- Expired.
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.