Vietnam MOH registration 2300651ĐKLH/BYT-HTTB

IVD Department quantitative Thyroglobulin test

VN: Bộ IVD xét nghiệm định lượng Thyroglobulin
Vietnam flagVietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·Theo theo phụ lục·Registered Jun 20, 2023
Registration details
Analysis ID
2300651ĐKLH/BYT-HTTB
Submission ID
19008902/ĐKLH-BYT-TB-CT
Product Type
Theo theo phụ lục
Product Code
Theo phụ lục
Company information
Manufacturer Country
Theo theo phụ lục
Technical details
Intended Use
ARCHITECT Thyroglobulin Calibrators: The ARCHITECT Thyroglobulin calibrators are used to calibrate the ARCHITECT iSystem when performing quantitative analysis of thyroglobulin (Tg) in human serum and plasma. ARCHITECT Thyroglobulin Controls: The ARCHITECT Thyroglobulin Controls are used to assess the accuracy of the test and to detect systematic errors in the ARCHITECT iSystem, when performing quantitative analysis of thyroglobulin (Tg) in human serum and plasma. ARCHITECT Thyroglobulin Reagent Kit: The ARCHITECT Thyroglobulin test is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative analysis of thyroglobulin in human serum and plasma on the ARCHITECT iSystem. The determination of thyroglobulin is used to support the monitoring of patients after undergoing total thyroidectomy.
Dates and status
Registration Date
Jun 20, 2023
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About this record

Access comprehensive regulatory information for IVD Department quantitative Thyroglobulin test 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 2300651ĐKLH/BYT-HTTB and manufactured by Theo theo phụ lục.

This page provides complete technical specifications, regulatory compliance details, 2 companies making similar products including Theo theo phụ lục, Beckman Coulter, Inc., and 2 recent registrations in the same category. 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.

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