Medical Device Division · registration 220362ActiveAbbott 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
- 220362
- Model name
- ARCHITECT STAT High Sensitive Troponin I Calibrators (3P25-02), ARCHITECT STAT High Sensitive Troponin I Controls (3P25-11), ARCHITECT STAT High Sensitive Troponin I Reagent Kit (3P25-26, 3P25-27, 3P25-36, 3P25-37)
- 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.