IVD Test Reagent/Kits, Serology, Virus, Hepatitis A, Antibody

体外诊断检测试剂/试剂盒、血清学、病毒、甲型肝炎、抗体

Siemens Healthcare Diagnostics Inc.·B·Hong Kong MDACS·Registered September 11, 2024

Device overview

Risk class: B
Product code: 17353
State: current
Status: N/A
Product code detail: 17353 IVD Test Reagent/Kits, Serology, Virus, Hepatitis A, Antibody

Manufacturer (製造商)

Name: Siemens Healthcare Diagnostics Inc.
Siemens Healthcare Diagnostics Inc
Country: United States
美国
Address: 511 Benedict Avenue, Tarrytown, NY 10591, United States
511 Benedict Avenue, 塔里敦, NY 10591, 美国

Authorised representative (AR)

Name: Siemens Healthcare Limited
西门子医疗有限公司
Phone: 25833388

Regulatory timeline

Registration date: September 11, 2024
Expiry date: September 10, 2029

Product models

Atellica IM Hepatitis A Total (aHAVT) (10995446), Atellica IM Hepatitis A Total Quality Control (aHAVT QC) (10995448)

Atellica IM 甲型肝炎总量 (aHAVT) (10995446)、Atellica IM 甲型肝炎总质量控制 (aHAVT QC) (10995448)

About this record

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

產品資訊： 体外诊断检测试剂/试剂盒、血清学、病毒、甲型肝炎、抗体