IVD Quantitative Inhibin A Test Kit
Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·Registered Nov 14, 2024- Analysis ID
- 2403594ĐKLH/BYT-HTTB
- Submission ID
- 000.00.04.G18-240801-0006
- 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 Inhibin A KRYPTOR (Product Code: 850075N): The B·R·A·H·M·S Inhibin A KRYPTOR test is an automated fluorescent immunoassay for the quantitative determination of the concentration of inhibin A dimer in human serum. The B·R·A·H·M·S Inhibin A KRYPTOR test is indicated as a supportive tool to be used in conjunction with clinical assessment to evaluate the non-invasive risk of trisomy 21 in the fetus in the second trimester of pregnancy. *) B·R·A·H·M·S Inhibin A KRYPTOR CAL (Product Code: 085091N): To correct the reference curve stored in the B·R·A·H·M·S KRYPTOR GOLD. *) B·R·A·H·M·S Inhibin A KRYPTOR QC (Product Code: 085092N): To monitor the quality of the test on the B·R·A·H·M·S KRYPTOR GOLD analyzer.
- Registration Date
- Nov 14, 2024
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Access comprehensive regulatory information for IVD Quantitative Inhibin A Test Kit 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 2403594ĐKLH/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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