190289

IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Surface Antibody

体外诊断检测试剂/试剂盒、血清学、病毒、乙型肝炎、表面抗体

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

Device overview

Risk class: D
Product code: 17359
State: current
Status: N/A
Product code detail: 17359 IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Surface Antibody

Manufacturer (製造商)

Name: Abbott Ireland Diagnostics Division
Abbott Ireland Diagnostics Division
Country: Ireland
爱尔兰
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: September 22, 2029

Product models

Alinity i Anti-HBs Reagent Kit (07P8922, 07P8932, 07P8952, 07P8957), Alinity i Anti-HBs Calibrators (07P8901), Alinity i Anti-HBs Controls (07P8910), Alinity i Anti-HBs Specimen Diluent (07P8942)

Alinity i 抗 HBs 试剂盒(07P8922、07P8932、07P8952、07P8957)、Alinity i 抗 HBs 校准品 (07P8901)、Alinity i 抗 HBs 质控品 (07P8910)、Alinity i 抗 HBs 样品稀释液 (07P8942)

About this record

This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Surface Antibody. 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, Serology, Virus, Hepatitis B, Surface Antibody

產品資訊： 体外诊断检测试剂/试剂盒、血清学、病毒、乙型肝炎、表面抗体