IVD Department quantitative analysis of human thyroglobulin (hTg) - Vietnam Registration 2403589ĐKLH/BYT-HTTB
Access comprehensive regulatory information for IVD Department quantitative analysis of human thyroglobulin (hTg) 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 2403589ĐKLH/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
2403589ĐKLH/BYT-HTTB
000.00.04.G18-240801-0023
Theo theo phụ lục
Theo phụ lục
Technical Details
*) B·R·A·H·M·S hTg sensitive KRYPTOR (Product Code: 832075N): The B·R·A·H·M·S hTg sensitive KRYPTOR is an automated fluorescent immunoassay to determine the quantitative concentration of human thyroglobulin (hTg) in serum. The B·R·A·H·M·S hTg sensitive KRYPTOR is indicated as a supportive tool to be used in combination with clinical assessment in the monitoring and surveillance of patients with differentiated thyroid carcinoma (papillary, follicular, or oncocytic type) after thyroidectomy. The test is also indicated to be used in combination with clinical assessment in the differential diagnosis of patients with congenital hypothyroidism and the diagnosis of patients suspected of having thyrotoxicosis factitia. *) B·R·A·H·M·S hTg sensitive KRYPTOR CAL (Product Code: 083291N): To correct the reference curve stored in the B·R·A·H·M·S KRYPTOR compact PLUS/ KRYPTOR GOLD. *) B·R·A·H·M·S hTg sensitive KRYPTOR QC (Product Code: 083292N): To monitor the quality of the test on the B·R·A·H·M·S KRYPTOR compact PLUS/ KRYPTOR GOLD.
Dates and Status
Nov 14, 2024