Vietnam MOH registration 2403596ĐKLH/BYT-HTTB

IVD Quantitative hCG+β Testing Department

VN: Bộ IVD xét nghiệm định lượng hCG+β

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

Registration details

Analysis ID: 2403596ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-240801-0005
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 hCG+β KRYPTOR (Product Code: 841050N): The B·R·A·H·M·S hCG+β KRYPTOR test is an automated fluorescent immunoassay for the quantitative determination of hCG+β (human chorionic gonadotropin and the free beta subunit of it) in human serum. The B·R·A·H·M·S hCG+β KRYPTOR test is indicated as a supportive tool to be used in combination with clinical assessment and other diagnostic results to evaluate the non-invasive risk of trisomy 21 and trisomy 18 of the fetus in the second trimester of pregnancy. *) B·R·A·H·M·S hCG+β KRYPTOR CAL (Product Code: 084191N): To calibrate the reference curve stored in the B·R·A·H·M·S KRYPTOR compact PLUS/ KRYPTOR GOLD. *) B·R·A·H·M·S hCG+β KRYPTOR QC (Product Code: 084192N): To monitor the quality of the test on the B·R·A·H·M·S KRYPTOR compact PLUS/ KRYPTOR GOLD. *) B·R·A·H·M·S hCG+β KRYPTOR QC high (Product Code: 084193N): To monitor the quality of the test on 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 Quantitative hCG+β Testing Department 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 2403596ĐKLH/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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