Medical Device Division · registration 230016ActiveAbbott
Hong KongIVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Surface AntibodyIVD Class DAbbott Ireland Diagnostics Division
Official record identity
- MDACS listing number
- 230016
- Model name
- ARCHITECT Anti-HBs Reagent Kit (7C18-29, 7C18-33, 7C18-39, 7C18-41, 7C18-42), ARCHITECT Anti-HBs Calibrators (7C18-03), ARCHITECT Anti-HBs Controls (7C18-13), ARCHITECT Anti-HBs Specimen Diluent (7C18-40)
- Registration date
- January 19, 2023
- Expiry date
- January 19, 2028
- Source update date
- September 09, 2025
- Status
- Active
Official value: Valid
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
- Abbott Laboratories Limited
- Manufacturer
- Abbott Ireland Diagnostics Division
Official description
IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Surface Antibody
Additional source fields
- AMD nomenclature code
- 17359
- Traditional Chinese local responsible person
- 美國雅培製藥有限公司
- Local responsible person phone
- 25668711
- Published manufacturer address
- Finisklin Business Park, Sligo, IRELAND
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.