HIV1/HIV2 antigen/antibody IVD, kit, enzyme immunoassay (EIA)

HIV1/HIV2 抗原/抗体体外诊断、试剂盒、酶免疫测定 (EIA)

BIO-RAD·D·Hong Kong MDACS·Registered February 03, 2021

Device overview

Risk class: D
Product code: N/A
State: current
Status: N/A

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: February 03, 2021
Expiry date: February 03, 2026

Product models

Genscreen ULTRA HIV Ag-Ab (72386, 72388)

About this record

This profile provides complete Hong Kong MDACS registration information for HIV1/HIV2 antigen/antibody IVD, kit, enzyme immunoassay (EIA). 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.