IVD Department Quantitative CEA Testing - Vietnam Registration 2403598ĐKLH/BYT-HTTB
Access comprehensive regulatory information for IVD Department Quantitative CEA 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 2403598ĐKLH/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
2403598ĐKLH/BYT-HTTB
000.00.04.G18-240801-0020
Theo theo phụ lục
Theo phụ lục
Technical Details
*) B·R·A·H·M·S CEA KRYPTOR (Product Code: 817100N): The B·R·A·H·M·S CEA KRYPTOR test is an automated fluorescent immunoassay for the quantitative determination of the concentration of carcinoembryonic antigen (CEA) in serum or plasma (EDTA, heparin). The B·R·A·H·M·S CEA KRYPTOR test is indicated as a supportive diagnostic tool, in combination with clinical assessment, for the monitoring and surveillance of patients with colorectal and breast adenocarcinoma as well as non-small cell lung cancer. *) B·R·A·H·M·S CEA KRYPTOR CAL (Product Code: 081791N): To calibrate the reference curve stored in the B·R·A·H·M·S KRYPTOR compact PLUS/ KRYPTOR GOLD.
Dates and Status
Nov 14, 2024