200430

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

体外诊断检测试剂/试剂盒、血清学、病毒、乙型肝炎、表面抗原

BIO-RAD·D·Hong Kong MDACS·Registered December 03, 2020

Device overview

Risk class: D
Product code: 17360
State: current
Status: N/A
Product code detail: 17360 IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Surface Antigen

Manufacturer (製造商)

Name: BIO-RAD
Bio-Rad
Address: 3 Boulevard Raymond Poincaré, 92430 MARNES LA COQUETTE FRANCE
3 大道雷蒙德庞加莱, 92430 马恩斯拉科撒娇联邦公报安斯

Authorised representative (AR)

Name: Bio-Rad Pacific Limited
Phone: 2789 3300 / 63365950

Regulatory timeline

Registration date: December 03, 2020
Expiry date: December 03, 2025

Product models

Monolisa HBs Ag ULTRA (72346, 72348)

单体 HBs 银超 (72346, 72348)

About this record

This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Surface 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 B, Surface 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、表面抗原