IVD Department quantitative PAPP-A testing
Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·Registered Nov 14, 2024- Analysis ID
- 2403550ĐKLH/BYT-HTTB
- Submission ID
- 000.00.04.G18-240801-0007
- 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 PAPP-A KRYPTOR (Product Code: 866075N): The B·R·A·H·M·S PAPP-A KRYPTOR test is an automated fluorescent immunoassay for the quantitative determination of the concentration of PAPP-A (Placental Protein 140) in human serum. The B·R·A·H·M·S PAPP-A KRYPTOR test is indicated as a supportive tool, in combination with clinical assessment, to assess the risk of trisomy 21, 18 and 13 in the fetus, and to evaluate the risk of preeclampsia in the first trimester of pregnancy. *) B·R·A·H·M·S PAPP-A KRYPTOR CAL (Product Code: 086691N): 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 PAPP-A 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 2403550ĐKLH/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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