Vietnam MOH registration 2400826ĐKLH/BYT-HTTB

Quantitative NT-proBNP Test Kit

VN: Bộ xét nghiệm định lượng NT-proBNP

Vietnam·Risk Class TTBYT Loại C·VIDAS® NT-proBNP2·BIOMERIEUX SA·Registered Jun 24, 2024

Registration details

Analysis ID: 2400826ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-220628-0001
Product Type: VIDAS® NT-proBNP2
Product Code: 30458

Company information

Manufacturer: BIOMERIEUX SA
Manufacturer Country: FRANCE
Product Owner: BIOMERIEUX SA
Authorized Representative: CÔNG TY TNHH BIOMÉRIEUX VIỆT NAM

Technical details

Intended Use: VIDAS NT-proBNP2 (PBN2) is an automated quantitative test performed on VIDAS devices to determine the concentration of the N-terminal fragment of the brain natriuretic peptide in human serum or plasma (lithium and sodium heparin) by the ELFA (Enzyme-Linked Fluorescence Assay) technique. The VIDAS NT-proBNP2 (PBN2) test is used to support the diagnosis of suspected heart failure.

Dates and status

Registration Date: Jun 24, 2024

About this record

Access comprehensive regulatory information for Quantitative NT-proBNP Test Kit in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại C medical device is registered under number 2400826ĐKLH/BYT-HTTB and manufactured by BIOMERIEUX SA. The authorized representative in Vietnam is CÔNG TY TNHH BIOMÉRIEUX VIỆT NAM.

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