IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Breast Cancer

体外诊断检测试剂/试剂盒, 免疫测定, 肿瘤标志物, 乳腺癌

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

Device overview

Risk class: C
Product code: 37582
State: current
Status: N/A
Product code detail: 37582 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Breast Cancer

Manufacturer (製造商)

Name: Siemens Healthcare Diagnostics Inc.
Siemens Healthcare Diagnostics Inc
Country: United States
美国
Address: 511 Benedict Ave, Tarrytown NY 10591, USA
511本尼迪克特大道,纽约塔里敦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 HER-2/neu (10995591), Atellica IM HER-2/neu Calibrator (10995592), Atellica IM HER-2/neu Quality Control (10995594)

Atellica IM HER-2/或(10995591)、Atellica IM HER-2/或校准器(10995592)、Atellica IM HER-2/或质量控制(10995594)

About this record

This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Breast Cancer. 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, Tumor Marker, Breast Cancer

產品資訊： 体外诊断检测试剂/试剂盒, 免疫测定, 肿瘤标志物, 乳腺癌