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Họ IVD lysing red blood cells in hematology testing - Vietnam Registration 240002678/PCBB-HN

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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240002678/PCBB-HN
Registration Details
Vietnam MOH Registration: 240002678/PCBB-HN
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Device Details

Họ IVD lysing red blood cells in hematology testing
VN: Họ IVD ly giải hồng cầu trong xét nghiệm huyết học
Risk Class TBYT Loại B

Registration Details

240002678/PCBB-HN

000.00.19.H26-241005-0001

Theo theo phụ lục

Theo phụ lục

Company Information

Theo theo phụ lục

B&E Bio-Technology Co., Ltd

Technical Details

(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

Oct 08, 2024