IVD Test Reagent/Kits, Immunohematology, Blood Grouping, ABO Typing

体外诊断测试试剂/试剂盒、免疫血液学、血型、ABO 分型

DiaMed Holding GmbH·D·Hong Kong MDACS·Registered November 11, 2020

Device overview

Risk class: D
Product code: 19295
State: current
Status: N/A
Product code detail: 19295 IVD Test Reagent/Kits, Immunohematology, Blood Grouping, ABO Typing

Manufacturer (製造商)

Name: DiaMed Holding GmbH
DiaMed Holding GmbH
Country: Switzerland
瑞士
Address: Pra Rond 23, 1785 Cressier FR, Switzerland
Pra Rond 23, 1785 克雷西耶联邦公报, 瑞士

Authorised representative (AR)

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

Regulatory timeline

Registration date: November 11, 2020
Expiry date: November 11, 2025

Product models

Bio-Rad ABO/Rh (50001), DiaClon ABO/Rh for Patients (50012), ABO/RhD (50031), ABO/Rh for Newborns (50061), DiaClon ABO/Rh for New Borns DVI- (50071), ABO/D + Reverse Grouping (50081), DiaClonABO/D + Reverse Grouping (50092), DiaClon ABO/D (50481), DiaClon ABO/D + DAT (50492), DiaClon ABO/Rh for Newborns DVI + (50961), DiaClon ABO/Rh for Donors (51011)

Bio-Rad ABO/Rh (50001), DiaClon ABO/Rh 患者 (50012), ABO/RhD (50031), ABO/Rh 新生儿 (50061), DiaClon ABO/Rh 新生儿 DVI- (50071), ABO/D + 反向分组 (50081), DiaClonABO/D + 反向分组 (50092), DiaClon ABO/D (50481), DiaClon ABO/D + DAT (50492), DiaClon ABO/Rh 用于新生儿 DVI+ (50961), DiaClon ABO/Rh 供体 (51011)

About this record

This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Immunohematology, Blood Grouping, ABO Typing. 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, Immunohematology, Blood Grouping, ABO Typing

產品資訊： 体外诊断测试试剂/试剂盒、免疫血液学、血型、ABO 分型