Vietnam MOH registration 240002470/PCBB-HCM

Thyroglobulin Antibody Quantitative Testing Assay

VN: Thuốc thử xét nghiệm định lượng kháng thể kháng thyroglobulin

Vietnam·Risk Class TBYT Loại B·Elecsys Anti-Tg·Roche Diagnostics (Suzhou) Ltd.·Registered Oct 28, 2024

Registration details

Analysis ID: 240002470/PCBB-HCM
Submission ID: 000.00.19.H29-241023-0001
Product Type: Elecsys Anti-Tg
Product Code: 09005021214

Company information

Manufacturer: Roche Diagnostics (Suzhou) Ltd.
Authorized Representative: CÔNG TY TNHH ROCHE VIỆT NAM

Technical details

Intended Use: In vitro immunoassay for quantifying antibodies against thyroglobulin in human serum and plasma. The quantification of anti-Tg antibodies is used to support the diagnosis of autoimmune thyroid disease. The electrochemiluminescence immunoassay “ECLIA” (electrochemiluminescence immunoassay “ECLIA”) is used in the cobas e immunoassay systems.

Dates and status

Registration Date: Oct 28, 2024

About this record

Access comprehensive regulatory information for Thyroglobulin Antibody Quantitative Testing Assay 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 240002470/PCBB-HCM and manufactured by Roche Diagnostics (Suzhou) Ltd.. The authorized representative in Vietnam is CÔNG TY TNHH ROCHE 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.