IVD Department quantitative antibody test for Thyroglobulin - Vietnam Registration 240000712/PCBB-HCM
Access comprehensive regulatory information for IVD Department quantitative antibody test for Thyroglobulin 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 240000712/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.
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Device Details
Registration Details
240000712/PCBB-HCM
000.00.19.H29-240111-0029
Theo theo phụ lục
Theo phụ lục
Technical Details
1/ The quantitative antibody test for Thyroglobulin (Type: ACCESS THYROGLOBULIN ANTIBODY II / Product Code: C86552): It is a fluorescent chemiluminescence, particle-enhanced immunoassay for the quantitative determination of thyroglobulin antibodies in human serum and plasma using the Access Immunoassay Systems. The measured value of the thyroglobulin autoantibody can support the diagnosis of Hashimoto's disease, non-toxic goiter, and Graves' disease. 2/ The quantitative antibody test for Thyroglobulin (Type: ACCESS THYROGLOBULIN ANTIBODY II CALIBRATORS / Product Code: A36920): It is used to calibrate the Access Thyroglobulin II antibody test for the quantitative determination of thyroglobulin antibodies in human serum and plasma using the Access Immunoassay Systems.
Dates and Status
Apr 04, 2024