IVD Department quantitative test for thyroglobulin-specific antibodies - Vietnam Registration 2403549ĐKLH/BYT-HTTB
Access comprehensive regulatory information for IVD Department quantitative test for thyroglobulin-specific antibodies 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 2403549ĐKLH/BYT-HTTB. The authorized representative in Vietnam is VĂN PHÒNG ĐẠI DIỆN LIFE TECHNOLOGIES HOLDINGS PTE. LTD. TẠI THÀNH PHỐ HỒ CHÍ MINH.
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Device Details
Registration Details
2403549ĐKLH/BYT-HTTB
000.00.04.G18-240801-0015
Theo theo phụ lục
Theo phụ lục
Technical Details
*) B·R·A·H·M·S anti-Tgn KRYPTOR (Product Code: 830075N): The B·R·A·H·M·S anti-Tgn KRYPTOR test is an automated fluorescent immunoassay to determine the quantitative concentration of anti-thyroglobulin (anti-Tg) autoantibodies in human serum and plasma (EDTA, heparin). The B·R·A·H·M·S anti-Tgn KRYPTOR test is indicated as a supportive tool to be used in conjunction with clinical assessment for the diagnosis of autoimmune thyroiditis and the monitoring of differentiated thyroid cancer patients. *) B·R·A·H·M·S anti-Tgn KRYPTOR CAL (Product Code: 083091N): To correct the reference curve stored in the B·R·A·H·M·S KRYPTOR compact PLUS/ KRYPTOR GOLD.
Dates and Status
Nov 14, 2024