IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, IgM Core Antibody

体外诊断检测试剂/试剂盒、血清学、病毒、乙型肝炎、IgM 核心抗体

Siemens Healthcare Diagnostics Inc·D·Hong Kong MDACS·Registered December 18, 2018

Device overview

Risk class: D
Product code: 17356
State: Expired.
Status: N/A
Product code detail: 17356 IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, IgM Core Antibody

Manufacturer (製造商)

Name: Siemens Healthcare Diagnostics Inc
Siemens Healthcare Diagnostics Inc
Country: United States
美国
Address: 511 Benedict Avenue, Tarrytown, New York 10591, USA
511 Benedict Avenue, Tarrytown, New York 10591, USA

Authorised representative (AR)

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

Regulatory timeline

Registration date: December 18, 2018
Expiry date: December 18, 2023

Product models

Atellica IM Hepatitis B Core Antigen (10995449), Atellica IM Hepatitis B Core Antigen Quality Control (10995450)

Atellica IM 乙型肝炎核心抗原 (10995449)、Atellica IM 乙型肝炎核心抗原质量控制 (10995450)

About this record

This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, IgM Core 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, IgM Core 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、IgM 核心抗体