Medical Device Division · registration 190373ActiveAbbott
Hong KongIVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Surface Antigen, ConfirmatoryIVD Class DAbbott Ireland Diagnostics Division
Official record identity
- MDACS listing number
- 190373
- Model name
- Alinity i HBsAg Qualitative II Confirmatory Manual Diluent (08P1140), Alinity i HBsAg Qualitative II Confirmatory Reagent Kit (08P1122), Alinity i HBsAg Qualitative II Controls (08P1010), Alinity i HBsAg Qualitative II Calibrators (08P1001)
- Registration date
- July 24, 2024
- Expiry date
- November 25, 2029
- Source update date
- December 19, 2025
- Status
- Active
Official value: Valid
Classification
- Risk class
- IVD Class D
- Published category
- IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Surface Antigen, Confirmatory
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 Antigen, Confirmatory
Additional source fields
- AMD nomenclature code
- 17361
- 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.