Vietnam MOH registration 240002389/PCBB-HN

The IVD functional thyroid marker cluster: FT3, FT4, T3, T4, TSH, Anti-TG, Anti-TPO

VN: Cụm IVD dấu ấn chức năng tuyến giáp: FT3, FT4, T3, T4, TSH, Anti-TG, Anti-TPO

Vietnam·Risk Class TBYT Loại B·Theo theo phụ lục·BIOMERIEUX SA·Registered Sep 12, 2024

Registration details

Analysis ID: 240002389/PCBB-HN
Submission ID: 000.00.19.H26-240828-0010
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: BIOMERIEUX SA
Manufacturer Country: Theo theo phụ lục
Product Owner: BIOMERIEUX SA
Authorized Representative: CÔNG TY TNHH BIOMÉRIEUX VIỆT NAM

Technical details

Intended Use: 30400: VIDAS® TSH is an automated quantitative assay for use on VIDAS® devices to determine the concentration of thyroid-stimulating hormone (TSH) in human serum or plasma (lithium heparin) by enzyme-linked immunofluorescence (ELISA). 30402: VIDAS® FT3 is an automated quantitative assay for use on VIDAS® devices to determine the concentration of free triiodothyronine (FT3) in human serum or plasma (lithium heparin) by enzyme-linked immunofluorescence (ELISA). 30403: VIDAS® T3 is an automated quantitative assay for use on VIDAS® devices to determine the concentration of total triiodothyronine (T3) in human serum or plasma (lithium heparin) by enzyme-linked immunofluorescence (ELISA). It is used to assist in the diagnosis of hyperthyroidism in adults. 30404: VIDAS® T4 is an automated quantitative assay for use on VIDAS® devices to determine the concentration of total thyroxine (T4) in human serum or plasma (lithium heparin) by enzyme-linked immunofluorescence (ELISA). VIDAS® T4 is designed to assist in the diagnosis of thyroid disorders in adults. 30441: VIDAS® TSH3 is an automated highly sensitive quantitative assay for use on VIDAS® devices to determine the concentration of human thyroid-stimulating hormone (TSH) in human serum or plasma (silicon tubes, gel-coated smooth tubes, or lithium heparin tubes) by enzyme-linked immunofluorescence (ELISA). 30459: VIDAS® FT4 (FT4N) is an automated quantitative assay for use on VIDAS® devices to determine the concentration of free thyroxine (FT4) in human serum or plasma (lithium heparin) by enzyme-linked immunofluorescence (ELISA). The measurement of free thyroxine is designed to be used as a diagnostic and monitoring tool for thyroid disorders. 30461: The VIDAS® Anti-TPO test is an automated quantitative assay for use on VIDAS® devices to determine the concentration of anti-thyroid peroxidase (anti-TPO) IgG autoantibodies in human serum or plasma by enzyme-linked immunofluorescence (ELISA). The VIDAS® Anti-TPO test is used to assist in the diagnosis of autoimmune thyroid disorders in adults with clinically apparent or subclinical thyroid dysfunction. 30462: The VIDAS® Anti-Tg test is an automated quantitative assay for use on VIDAS® devices to determine the concentration of anti-thyroglobulin (anti-Tg) IgG autoantibodies in human serum or plasma by enzyme-linked immunofluorescence (ELISA). The VIDAS® Anti-Tg test is designed to assist in the diagnosis of autoimmune thyroid disorders.

Dates and status

Registration Date: Sep 12, 2024

About this record

Access comprehensive regulatory information for The IVD functional thyroid marker cluster: FT3, FT4, T3, T4, TSH, Anti-TG, Anti-TPO 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 240002389/PCBB-HN and manufactured by BIOMERIEUX SA. The authorized representative in Vietnam is CÔNG TY TNHH BIOMÉRIEUX VIỆT NAM.

This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 300,000+ Vietnamese medical device registrations, helping global MedTech companies navigate Vietnam MOH regulations, identify competitors, and discover partnership opportunities efficiently.