Vietnam MOH registration 240003167/PCBB-HN

IVD Globulin Immune Complex: IgA; IgM; IgG

VN: Cụm IVD Globulin miễn dịch: IgA; IgM; IgG

Vietnam·Risk Class TBYT Loại B·Theo theo phụ lục·APTEC DIAGNOSTICS NV·Registered Nov 19, 2024

Registration details

Analysis ID: 240003167/PCBB-HN
Submission ID: 000.00.19.H26-241113-0040
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: APTEC DIAGNOSTICS NV
Manufacturer Country: Theo theo phụ lục
Product Owner: APTEC DIAGNOSTICS NV
Authorized Representative: CÔNG TY TNHH KHOA HỌC KỸ THUẬT HƯỚNG DƯƠNG

Technical details

Intended Use: The quantitative IgA test is used to determine the concentration of IgA in human serum by immunodiffusion turbidimetry; The quantitative IgG test is used to determine the concentration of IgG in human serum by immunodiffusion turbidimetry; The quantitative IgM test is used to determine the concentration of IgM in human serum by immunodiffusion turbidimetry

Dates and status

Registration Date: Nov 19, 2024

About this record

Access comprehensive regulatory information for IVD Globulin Immune Complex: IgA; IgM; IgG 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 240003167/PCBB-HN and manufactured by APTEC DIAGNOSTICS NV. The authorized representative in Vietnam is CÔNG TY TNHH KHOA HỌC KỸ THUẬT HƯỚNG DƯƠNG.

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