Vietnam MOH registration 240002678/PCBB-HN

Họ IVD lysing red blood cells in hematology testing

VN: Họ IVD ly giải hồng cầu trong xét nghiệm huyết học

Vietnam·Risk Class TBYT Loại B·Theo theo phụ lục·B&E Bio-Technology Co., Ltd·Registered Oct 08, 2024

Registration details

Analysis ID: 240002678/PCBB-HN
Submission ID: 000.00.19.H26-241005-0001
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: B&E Bio-Technology Co., Ltd
Manufacturer Country: Theo theo phụ lục
Product Owner: B&E Bio-Technology Co., Ltd
Authorized Representative: CÔNG TY TNHH Y TẾ MINH NHẬT

Technical details

Intended Use: (For in vitro diagnostic use only) Lyse-BC is used as a hemolysis reagent in the Mindray 3-part blood analysis autoanalyzer to measure hemoglobin concentration and the number of blood cells. Lyse-BC was used as a hemolysis reagent in the older BC-5200/BC-5500 and BC5600/5800 blood analysis autoanalyzer to measure hemoglobin concentration.

Dates and status

Registration Date: Oct 08, 2024

About this record

Access comprehensive regulatory information for Họ IVD lysing red blood cells in hematology testing in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TBYT Loại B medical device is registered under number 240002678/PCBB-HN and manufactured by B&E Bio-Technology Co., Ltd. The authorized representative in Vietnam is CÔNG TY TNHH Y TẾ MINH NHẬT.

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