Vietnam MOH registration 2403405ĐKLH/BYT-HTTB

Quantitative Test Card NT-proBNP

VN: Thẻ xét nghiệm định lượng NT-proBNP

Vietnam·Risk Class TTBYT Loại C·STANDARD™ F NT-proBNP FIA·SD Biosensor, Inc.·Registered Nov 06, 2024

Registration details

Analysis ID: 2403405ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-201231-0026
Product Type: STANDARD™ F NT-proBNP FIA
Product Code: F-NTP-01

Company information

Manufacturer: SD Biosensor, Inc.
Manufacturer Country: REPUBLIC OF
Product Owner: SD Biosensor, Inc.
Authorized Representative: CÔNG TY CỔ PHẦN Y TẾ ĐỨC MINH

Technical details

Intended Use: STANDARD™ F NT – proBNP FIA is an in vitro diagnostic test for quantifying the concentration of N-terminal pro B-type Natriuretic peptide (NT – proBNP) in serum and whole blood samples. The quantification of NT-proBNP is useful in diagnosing both acute and chronic heart failure.

Dates and status

Registration Date: Nov 06, 2024

About this record

Access comprehensive regulatory information for Quantitative Test Card NT-proBNP 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 2403405ĐKLH/BYT-HTTB and manufactured by SD Biosensor, Inc.. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN Y TẾ ĐỨC MINH.

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