Medical Device Division · registration 230399ActiveAbbott
Hong KongIVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Surface AntigenIVD Class DAbbott Ireland, Diagnostics Division
Official record identity
- MDACS listing number
- 230399
- Model name
- ARCHITECT HBsAg Next Qualitative Calibrators ( 4P76-01), ARCHITECT HBsAg Next Qualitative Controls ( 4P76-10), ARCHITECT HBsAg Next Qualitative Reagent Kit ( 4P76-25, 4P76-30, 4P76-35)
- Registration date
- October 25, 2023
- Expiry date
- October 25, 2028
- Source update date
- July 22, 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
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.