190029

IVD Test Reagent/Kits, Serology, Virus, Hepatitis Be, Antigen

体外诊断检测试剂/试剂盒、血清学、病毒、乙型肝炎、抗原

Siemens Healthcare Diagnostics Inc·D·Hong Kong MDACS·Registered January 24, 2019

Device overview

Risk class: D
Product code: 19060
State: Expired.
Status: N/A
Product code detail: 19060 IVD Test Reagent/Kits, Serology, Virus, Hepatitis Be, Antigen

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: January 24, 2019
Expiry date: January 24, 2024

Product models

Atellica IM Hepatitis B e Antigen (10995600), Atellica IM Hepatitis B e Antigen Quality Control (10995601)

Atellica IM 乙型肝炎 e 抗原 (10995600), Atellica IM 乙型肝炎 e 抗原质量控制 (10995601)

About this record

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

產品資訊： 体外诊断检测试剂/试剂盒、血清学、病毒、乙型肝炎、抗原