Medical Device Division · registration 190362ActiveAbbott
Hong KongIVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Surface AntigenIVD Class DAbbott Ireland Diagnostics Division
Official record identity
- MDACS listing number
- 190362
- Model name
- Alinity i HBsAg Reagent Kit (08P0822, 08P0832, 08P0852, 08P0857), Alinity i HBsAg Calibrators (08P0801), Alinity i HBsAg Controls (08P0810), Alinity i HBsAg Manual Diluent (08P0843)
- Registration date
- August 08, 2024
- Expiry date
- November 04, 2029
- Source update date
- September 15, 2025
- Status
- Active
Official value: Valid
Classification
- Risk class
- IVD Class D
- Published category
- IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Surface Antigen
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
Additional source fields
- AMD nomenclature code
- 17360
- 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.