Medical Device Division · registration 220361ActiveAbbott Ireland, Diagnostics Division
Hong KongIVD Test Reagent/Kits, Immunoassay, Cardiac Marker, Protein, Troponin-IIVD Class CAbbott Ireland, Diagnostics Division
Official record identity
- MDACS listing number
- 220361
- Model name
- Alinity i STAT High Sensitive Troponin-I Calibrators (08P13-01), Alinity i STAT High Sensitive Troponin-I Controls (08P13-10), Alinity i STAT High Sensitive Troponin-I Reagent Kit (08P13-22, 08P13-24, 08P13-27, 08P13-32, 08P13-34, 08P13-37)
- Registration date
- November 03, 2022
- Expiry date
- November 03, 2027
- Source update date
- August 21, 2023
- Status
- Active
Official value: Valid
Classification
- Risk class
- IVD Class C
- Published category
- IVD Test Reagent/Kits, Immunoassay, Cardiac Marker, Protein, Troponin-I
Official value: C
Published parties
- Registrant / registration holder
- Abbott Laboratories Limited
- Manufacturer
- Abbott Ireland, Diagnostics Division
Official description
IVD Test Reagent/Kits, Immunoassay, Cardiac Marker, Protein, Troponin I
Additional source fields
- AMD nomenclature code
- 19689
- Traditional Chinese local responsible person
- 美國雅培製藥有限公司
- Local responsible person phone
- 25668711
- Published manufacturer address
- Lisnamuck, Longford, Co. Longford, 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.