IVD Department quantitative sFlt-1 testing - Vietnam Registration 2403591ĐKLH/BYT-HTTB
Access comprehensive regulatory information for IVD Department quantitative sFlt-1 testing 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 2403591ĐKLH/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
2403591ĐKLH/BYT-HTTB
000.00.04.G18-240801-0010
Theo theo phụ lục
Theo phụ lục
Technical Details
*) B·R·A·H·M·S sFlt-1 KRYPTOR (Product Code: 845075N): The B·R·A·H·M·S sFlt-1 KRYPTOR test is an automated fluorescent immunoassay to determine the concentration of soluble fms-like tyrosine kinase-1 (sFlt-1), also known as VEGF receptor-1, in human plasma and serum (EDTA). The B·R·A·H·M·S sFlt-1 KRYPTOR test is indicated as a supportive tool to be used in combination with clinical assessment to evaluate the non-invasive risk of developing preeclampsia in the second and third trimesters of pregnancy. The B·R·A·H·M·S sFlt-1 KRYPTOR test is indicated as a supportive tool to be used in combination with the B·R·A·H·M·S PlGF plus KRYPTOR test and clinical assessment for diagnosis and/or short-term prognosis of preeclampsia in women at risk of preeclampsia. *) B·R·A·H·M·S sFlt-1 KRYPTOR CAL (Product Code: 084591N): To calibrate the reference standard stored in the B·R·A·H·M·S KRYPTOR compact PLUS/ KRYPTOR GOLD. *) B·R·A·H·M·S sFlt-1 KRYPTOR QC (Product Code: 084592N): To control the quality of the test on the B·R·A·H·M·S KRYPTOR compact PLUS/ KRYPTOR GOLD.
Dates and Status
Nov 14, 2024