Medical Device Division · registration 240290ActiveAbbott Ireland Diagnostics Division
Hong KongIVD Test Reagent/Kits, Immunoassay, Tumor Marker, Oncofetal, Carcinoembryonic AntigenIVD Class CAbbott Ireland Diagnostics Division
Official record identity
- MDACS listing number
- 240290
- Model name
- Alinity i CEA Reagent Kit (07P6220, 07P6230), Alinity i CEA Controls (07P6210), Alinity i CEA Calibrators (07P6201)
- Registration date
- August 08, 2024
- Expiry date
- August 07, 2029
- Source update date
- March 30, 2026
- Status
- Active
Official value: Valid
Classification
- Risk class
- IVD Class C
- Published category
- IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Oncofetal, Carcinoembryonic Antigen
Official value: C
Published parties
- Registrant / registration holder
- Abbott Laboratories Limited
- Manufacturer
- Abbott Ireland Diagnostics Division
Official description
IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Oncofetal, Carcinoembryonic Antigen
Additional source fields
- AMD nomenclature code
- 17293
- 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.