Thyroglobulin Antibody Quantitative Testing Assay - Vietnam Registration 240002470/PCBB-HCM
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.
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Device Details
Registration Details
240002470/PCBB-HCM
000.00.19.H29-241023-0001
Elecsys Anti-Tg
09005021214
Technical Details
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
Oct 28, 2024