The IVD Department quantitatively tests the protein of the perineuronal net with acidic properties (GFAP) and ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1)
Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·Registered Nov 02, 2024- Analysis ID
- 2403228ĐKLH/BYT-HTTB
- Submission ID
- 000.00.04.G18-231116-0018
- 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
- The GFAP Calibrators are used to calibrate the Alinity i system when quantifying the protein of the perineuronal net with acidic properties (GFAP) in human serum and plasma. For more information, refer to the Assay Manual and the Alinity ci-series Operations Manual. The GFAP Controls are used to assess the accuracy of the test and the analytical system of the Alinity i system, when quantifying the protein of the perineuronal net with acidic properties (GFAP) in human serum and plasma. For more information, refer to the Assay Manual and the Alinity ci-series Operations Manual. The UCH-L1 Calibrators are used to calibrate the Alinity i system when quantifying ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1) in human serum and plasma. For more information, refer to the Assay Manual and the Alinity ci-series Operations Manual. The UCH-L1 Controls are used to assess the accuracy of the test and the analytical system of the Alinity i system, when quantifying ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1) in human serum and plasma. For more information, refer to the Assay Manual and the Alinity ci-series Operations Manual. The TBI Assay is a fluorescent bead-based immunoassay (CMIA) for in vitro diagnosis to quantify the protein of the perineuronal net with acidic properties (GFAP) and ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1) in human serum and plasma, and to interpret the results of the semiquantitative analysis of these analytes through the Alinity i system. The interpretation of the test results is combined with clinical information to support the evaluation of patients 18 years of age and older, who are suspected of having mild traumatic brain injury (mTBI) with a Glasgow Coma Scale score of 13-15, within 12 hours of the injury, to support the decision whether to perform a head CT (Computed Tomography) scan. Negative test results are associated with no acute intracranial injury on the head CT scan. The TBI Assay is intended for use in the laboratory by qualified medical professionals.
- Registration Date
- Nov 02, 2024
Access comprehensive regulatory information for The IVD Department quantitatively tests the protein of the perineuronal net with acidic properties (GFAP) and ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1) 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 2403228ĐKLH/BYT-HTTB. The authorized representative in Vietnam is VĂN PHÒNG ĐẠI DIỆN ABBOTT LABORATORIES GMBH TẠI THÀNH PHỐ HÀ NỘI.
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