IVD Test Reagent/Kits, Immunoassay, Pregnancy Protein, Alpha-Fetoprotein

体外诊断测试试剂/试剂盒、免疫测定、妊娠蛋白、甲胎蛋白

Abbott Ireland Diagnostics Division·C·Hong Kong MDACS·Registered August 08, 2024

Device overview

Risk class: C
Product code: 17259
State: current
Status: N/A
Product code detail: 17259 IVD Test Reagent/Kits, Immunoassay, Pregnancy Protein, Alpha-Fetoprotein

Manufacturer (製造商)

Name: Abbott Ireland Diagnostics Division
Abbott Ireland Diagnostics Division
Address: Finisklin Business Park, Sligo, IRELAND
菲尼斯克林商业园,爱尔兰斯莱戈

Authorised representative (AR)

Name: Abbott Laboratories Limited
美国雅培制药有限公司
Phone: 25668711, 98615786

Regulatory timeline

Registration date: August 08, 2024
Expiry date: August 07, 2029

Product models

Alinity i AFP Reagent Kit (07P9020, 07P9030), Alinity i AFP Calibrators (07P9001), Alinity i AFP Controls (07P9010)

Alinity i AFP 试剂盒 (07P9020、07P9030)、Alinity i AFP 校准品 (07P9001)、Alinity i AFP 对照品 (07P9010)

About this record

This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Immunoassay, Pregnancy Protein, Alpha-Fetoprotein. Review device classification, authorised representative (AR) details, manufacturer contacts, product codes, and regulatory milestones. Pure Global AI delivers bilingual transparency for medical device registrations across Asia.

Product Info: IVD Test Reagent/Kits, Immunoassay, Pregnancy Protein, Alpha-Fetoprotein

產品資訊： 体外诊断测试试剂/试剂盒、免疫测定、妊娠蛋白、甲胎蛋白