IVD Department quantitative and qualitative analysis of the beta (β-hCG) membrane-bound human chorionic gonadotropin (hCG)
Vietnam·Risk Class TBYT Loại B·Theo theo phụ lục·Registered Oct 02, 2024- Analysis ID
- 240002608/PCBB-HN
- Submission ID
- 000.00.19.H26-240910-0016
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Authorized Representative
- VĂN PHÒNG ĐẠI DIỆN ABBOTT LABORATORIES GMBH TẠI THÀNH PHỐ HÀ NỘI
- Intended Use
- Alinity i Total β-hCG Calibrators are used to calibrate the Alinity i analyzer when performing qualitative and quantitative analysis of beta human chorionic gonadotropin (β-hCG) in human serum and plasma. For more information, refer to the Alinity i Total β-hCG Assay Manual and the Alinity ci-series Operations Manual. Alinity i Total β-hCG Controls are used to control the quality of the Alinity i Total β-hCG assay in human serum or plasma. For more information, refer to the Alinity i Total β-hCG Assay Manual and the Alinity ci-series Operations Manual. The Alinity i Total β-hCG assay is a chemiluminescent microparticle immunoassay (CMIA) used to quantitate and qualitate the human chorionic gonadotropin beta (β-hCG) in human serum and plasma, to detect early pregnancy on the Alinity i analyzer.
- Registration Date
- Oct 02, 2024
Access comprehensive regulatory information for IVD Department quantitative and qualitative analysis of the beta (β-hCG) membrane-bound human chorionic gonadotropin (hCG) in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TBYT Loại B medical device is registered under number 240002608/PCBB-HN. The authorized representative in Vietnam is VĂN PHÒNG ĐẠI DIỆN ABBOTT LABORATORIES GMBH TẠI THÀNH PHỐ HÀ NỘI.
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