Medical Device Division · registration 240201Active

Abbott Ireland Diagnostics Division

Name: Abbott Ireland Diagnostics Division — Medical Device Division 240201
Creator: Abbott Ireland Diagnostics Division
Keywords: Abbott Ireland Diagnostics Division, Abbott Ireland Diagnostics Division, 240201, IVD Test Reagent/Kits, Immunoassay, Brain Trauma, Medical Device Division

Hong KongIVD Test Reagent/Kits, Immunoassay, Brain TraumaIVD Class CAbbott Ireland Diagnostics Division

Verified

Official record identity

MDACS listing number: 240201
Model name: GFAP Reagent Kit (4W16-25), GFAP Calibrators (4W16-01), GFAP Controls (4W16-10), UCH-L1 Reagent Kit (4W18-25), UCH-L1 Calibrators (4W18-01), UCH-L1 Controls (4W18-10), TBI (04Z22)
Registration date: June 04, 2024
Expiry date: June 03, 2029
Source update date: January 30, 2026
Status: Active

Classification

Risk class: IVD Class C
Published category: IVD Test Reagent/Kits, Immunoassay, Brain Trauma

Published parties

Registrant / registration holder: Abbott Laboratories Limited
Manufacturer: Abbott Ireland Diagnostics Division

Official description

IVD Test Reagent/Kits, Immunoassay, Brain Trauma

Additional source fields

AMD nomenclature code: 40103
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.