200496

IVD Test Reagent/Kits, Serology, Virus, Retrovirus, HIV-1, Antigen

体外诊断检测试剂/试剂盒、血清学、病毒、逆转录病毒、HIV-1、抗原

BIO-RAD·D·Hong Kong MDACS·Registered December 08, 2020

Device overview

Risk class: D
Product code: 19066
State: current
Status: N/A
Product code detail: 19066 IVD Test Reagent/Kits, Serology, Virus, Retrovirus, HIV-1, 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 马恩斯拉科娇特, 联邦公报安斯

Authorised representative (AR)

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

Regulatory timeline

Registration date: December 08, 2020
Expiry date: December 08, 2025

Product models

Genscreen HIV-1 Ag Assay (71120), Genscreen HIV-1 Ag Confirmatory Assay (71121)

基因筛查 HIV-1 抗原检测 (71120)、基因筛查 HIV-1 抗原确认检测 (71121)

About this record

This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Serology, Virus, Retrovirus, HIV-1, 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, Retrovirus, HIV-1, Antigen

產品資訊： 体外诊断检测试剂/试剂盒、血清学、病毒、逆转录病毒、HIV-1、抗原