IVD Department quantitative CA 15-3 - Vietnam Registration 2403600ĐKLH/BYT-HTTB
Access comprehensive regulatory information for IVD Department quantitative CA 15-3 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 2403600ĐKLH/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, 2 companies making similar products including Beckman Coulter, Inc., Theo phụ lục, and 2 recent registrations in the same category. 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.
Device Details
Registration Details
2403600ĐKLH/BYT-HTTB
000.00.04.G18-240801-0018
Theo theo phụ lục
Theo phụ lục
Technical Details
*) B·R·A·H·M·S CA 15-3 KRYPTOR (Product Code: 808075N): The B·R·A·H·M·S CA 15-3 KRYPTOR test is an automated fluorescent immunoassay for the quantitative determination of the concentration of the cancer antigen 15-3 (CA 15-3) in serum or plasma (EDTA, heparin). The B·R·A·H·M·S CA 15-3 KRYPTOR test is indicated as a supportive tool to be used in combination with clinical assessment to monitor and assess the treatment of breast cancer patients. *) B·R·A·H·M·S CA 15-3 KRYPTOR CAL (Product Code: 080891N): 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