Vietnam MOH registration 2403599ĐKLH/BYT-HTTB

IVD Department quantitative CA 19-9

VN: Bộ IVD xét nghiệm định lượng CA 19-9

Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·Registered Nov 14, 2024

Registration details

Analysis ID: 2403599ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-240801-0019
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Authorized Representative: VĂN PHÒNG ĐẠI DIỆN LIFE TECHNOLOGIES HOLDINGS PTE. LTD. TẠI THÀNH PHỐ HỒ CHÍ MINH

Technical details

Intended Use: *) 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

Registration Date: Nov 14, 2024

About this record

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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