Vietnam MOH registration 2403549ĐKLH/BYT-HTTB

IVD Department quantitative test for thyroglobulin-specific antibodies

VN: Bộ IVD xét nghiệm định lượng tự kháng thể kháng thyroglobulin

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

Registration details

Analysis ID: 2403549ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-240801-0015
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 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

Registration Date: Nov 14, 2024

About this record

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.

This page provides complete technical specifications, regulatory compliance details. 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.