IVD Department quantitative CA 19-9 - Vietnam Registration 2403599ĐKLH/BYT-HTTB
Access comprehensive regulatory information for IVD Department quantitative CA 19-9 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 2403599ĐKLH/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
2403599ĐKLH/BYT-HTTB
000.00.04.G18-240801-0019
Theo theo phụ lục
Theo phụ lục
Technical Details
*) B·R·A·H·M·S CA 19-9 KRYPTOR (Product Code: 807100N): The B·R·A·H·M·S CA 19-9 KRYPTOR test is an automated fluorescent immunoassay for the quantitative determination of the concentration of carbohydrate antigen 19-9 (CA 19-9) in serum or plasma (EDTA, heparin). The B·R·A·H·M·S CA 19-9 KRYPTOR test is indicated as a supportive diagnostic tool, in combination with clinical assessment, for the monitoring and surveillance of patients with pancreatic cancer, bile duct cancer, or stomach cancer. *) B·R·A·H·M·S CA 19-9 KRYPTOR CAL (Product Code: 080791N): 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