Medical Device Division · registration 190289ActiveAbbott
Hong KongIVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Surface AntibodyIVD Class DAbbott Ireland Diagnostics Division
Official record identity
- MDACS listing number
- 190289
- Model name
- Alinity i Anti-HBs Reagent Kit (07P8922, 07P8932, 07P8952, 07P8957), Alinity i Anti-HBs Calibrators (07P8901), Alinity i Anti-HBs Controls (07P8910), Alinity i Anti-HBs Specimen Diluent (07P8942)
- Registration date
- August 08, 2024
- Expiry date
- September 22, 2029
- Source update date
- August 20, 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
- Revision number
- a
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.