IVD Department quantitative AFP testing - Vietnam Registration 2403601ĐKLH/BYT-HTTB
Access comprehensive regulatory information for IVD Department quantitative AFP 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 2403601ĐKLH/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
2403601ĐKLH/BYT-HTTB
000.00.04.G18-240801-0003
Theo theo phụ lục
Theo phụ lục
Technical Details
*) B·R·A·H·M·S AFP KRYPTOR (Product Code: 816075N): The B·R·A·H·M·S AFP KRYPTOR test is an automated fluorescent immunoassay for the quantitative determination of alpha-fetoprotein (AFP) concentration in serum, plasma (heparin), and amniotic fluid. The B·R·A·H·M·S AFP KRYPTOR test is indicated for use in conjunction with other test results and clinical data as a non-invasive screening tool for the risk of trisomy 21 in the fetus in the first trimester and trisomy 21 and 18 in the fetus in the second trimester of pregnancy. The B·R·A·H·M·S AFP KRYPTOR test is indicated as a non-invasive screening tool, used in conjunction with clinical evaluation, to assess the risk of neural tube defects in the fetus in serum and plasma (heparin) and to diagnose neural tube defects in the fetus in amniotic fluid in the second trimester of pregnancy. The B·R·A·H·M·S AFP KRYPTOR test is indicated as a non-invasive screening tool, used in conjunction with clinical evaluation, in the diagnosis of patients suspected of having hepatocellular carcinoma or non-seminomatous germ cell tumors (NSGCTs) and in the monitoring of patients confirmed to have hepatocellular carcinoma or NSGCTs. *) B·R·A·H·M·S AFP KRYPTOR CAL (Product Code: 081691N): To correct the calibration standard stored in the B·R·A·H·M·S KRYPTOR compact PLUS/ KRYPTOR GOLD.
Dates and Status
Nov 14, 2024