Vietnam MOH registration 2403589ĐKLH/BYT-HTTB

IVD Department quantitative analysis of human thyroglobulin (hTg)

VN: Bộ IVD xét nghiệm định lượng thyroglobulin người (hTg)

Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·Registered Nov 14, 2024

Registration details

Analysis ID: 2403589ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-240801-0023
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Authorized Representative: VĂN PHÒNG ĐẠI DIỆN LIFE TECHNOLOGIES HOLDINGS PTE. LTD. TẠI THÀNH PHỐ HỒ CHÍ MINH

Technical details

Intended Use: *) 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

Registration Date: Nov 14, 2024

About this record

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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