Vietnam MOH registration 2403598ĐKLH/BYT-HTTB

IVD Department Quantitative CEA Testing

VN: Bộ IVD xét nghiệm định lượng CEA

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

Registration details

Analysis ID: 2403598ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-240801-0020
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 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

Registration Date: Nov 14, 2024

About this record

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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