IVD Department quantitative Thyroglobulin test - Vietnam Registration 240000711/PCBB-HCM
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 B medical device is registered under number 240000711/PCBB-HCM and manufactured by Beckman Coulter, Inc.. The authorized representative in Vietnam is VĂN PHÒNG ĐẠI DIỆN BECKMAN COULTER HONG KONG LIMITED TẠI TPHCM.
This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including Theo theo phụ lục, 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.
Device Details
Registration Details
240000711/PCBB-HCM
000.00.19.H29-240111-0028
Theo theo phụ lục
Theo phụ lục
Technical Details
1/ The Thyroglobulin Quantitative Assay (Type: ACCESS THYROGLOBULIN/ Product Code: C71762): It is a fluorescent, chemiluminescent immunoassay for the quantitative determination of thyroglobulin in human serum and plasma by the Access Immunoassay Systems. The device is intended to support the monitoring of the presence of localized and metastatic thyroid tissue in patients who have undergone thyroidectomy (with or without radiotherapy) and in individuals who are deficient in thyroglobulin antibodies in the serum. 2/ The Thyroglobulin Quantitative Assay Calibration Standards (Type: ACCESS THYROGLOBULIN CALIBRATORS/ Product Code: 33865): Used to calibrate the Access Thyroglobulin Assay for the quantitative determination of thyroglobulin in human serum and plasma by the Access Immunoassay Systems.
Dates and Status
Apr 04, 2024