IVD Department quantitative CA 15-3
Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·Registered Nov 14, 2024- Analysis ID
- 2403600ĐKLH/BYT-HTTB
- Submission ID
- 000.00.04.G18-240801-0018
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Authorized Representative
- VĂN PHÒNG ĐẠI DIỆN LIFE TECHNOLOGIES HOLDINGS PTE. LTD. TẠI THÀNH PHỐ HỒ CHÍ MINH
- Intended Use
- *) 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.
- Registration Date
- Nov 14, 2024
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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.
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