140399

IVD Test Reagent/Kits, Serology, Virus, Retrovirus, HIV-1/2

体外诊断 检测试剂/试剂盒、血清学、病毒、逆转录病毒、HIV-1/2
BIO-RAD LABORATORIES CLINICAL DIAGNOSTICS GROUP·D·Hong Kong MDACS·Registered October 07, 2024
Device overview
Risk class
D
Product code
19430
State
current
Status
N/A
Product code detail
19430 IVD Test Reagent/Kits, Serology, Virus, Retrovirus, HIV-1/2
Manufacturer (製造商)
Name
BIO-RAD LABORATORIES CLINICAL DIAGNOSTICS GROUP
BIO-RAD LABORATORIES CLINICAL DIAGNOSTICS GROUP
Address
4000 Alfred Nobel Drive, HERCULES, CA - 94547, UNITED STATES
4000阿尔弗雷德诺贝尔驱动器, 赫拉克勒斯, CA - 94547, 美国
Authorised representative (AR)
Phone
2789 3300 / 63365950
Regulatory timeline
Registration date
October 07, 2024
Expiry date
November 13, 2029
Product models
BioPlex 2200 HIV Ag-Ab (665-3450), BioPlex 2200 HIV Ag-Ab Calibrator set (663-3400), BioPlex 2200 HIV Ag-Ab Control set (663-3430)
BioPlex 2200 HIV Ag-Ab (665-3450)、BioPlex 2200 HIV Ag-Ab 校准品套装 (663-3400)、BioPlex 2200 HIV Ag-Ab 对照套装 (663-3430)
About this record

This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Serology, Virus, Retrovirus, HIV-1/2. 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-1/2

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-1/2