Vietnam MOH registration 2403541ĐKLH/BYT-HTTB

Quantitative Lymphocyte Assay Test Drug

VN: Thuốc thử xét nghiệm định lượng tế bào lympho

Vietnam·Risk Class TBYT Loại C·Flow-Count Fluorospheres·Beckman Coulter, Inc.·Registered Nov 14, 2024

Registration details

Analysis ID: 2403541ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-211125-0018
Product Type: Flow-Count Fluorospheres
Product Code: 7547053

Company information

Manufacturer: Beckman Coulter, Inc.
Manufacturer Country: UNITED STATES
Product Owner: Beckman Coulter, Inc.
Authorized Representative: CÔNG TY TNHH KỸ THUẬT NAM PHƯƠNG

Technical details

Intended Use: Flow-Count Flourospheres contain fluorescent microbeads, used to directly determine the number of lymphocytes, the percentage and absolute number of different types of lymphocytes in the sample when used on flow cytometry instruments: Cytomics FC 500, Navios and Navios EX. In addition, Flow-Count Flourospheres are also used to determine the percentage and absolute number of CD34+ cells in the sample when used on the Cytomics FC 500 flow cytometry instrument.

Dates and status

Registration Date: Nov 14, 2024

About this record

Access comprehensive regulatory information for Quantitative Lymphocyte Assay Test Drug in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TBYT Loại C medical device is registered under number 2403541ĐKLH/BYT-HTTB and manufactured by Beckman Coulter, Inc.. The authorized representative in Vietnam is CÔNG TY TNHH KỸ THUẬT NAM PHƯƠNG.

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