IVD Quantitative D-Dimer Test Kit
Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Theo theo phụ lục·Registered Aug 16, 2023- Analysis ID
- 230001943/PCBB-HN
- Submission ID
- 000.00.19.H26-230731-0003
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Manufacturer
- Theo theo phụ lục
- Manufacturer Country
- Theo theo phụ lục
- Intended Use
- The D-Dimer test is used to quantify D-Dimer in citrated human blood on the Alinity c system. The D-Dimer test is used to support the diagnosis of thrombosis and to monitor the treatment of fibrinolysis. Elevated levels of D-Dimer are observed in clinical conditions such as deep vein thrombosis (DVT), pulmonary embolism (PE), and disseminated intravascular coagulation (DIC). The concentration of D-Dimer also increases in normal pregnancy, but very high concentrations are associated with complications. The D-Dimer Calibrator is used to calibrate the Alinity c system when performing the quantification of D-Dimer in citrated human blood. The D-Dimer Controls are used to estimate the accuracy and analytical variability of the Alinity c system when performing the quantification of D-Dimer in citrated human blood.
- Registration Date
- Aug 16, 2023
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Access comprehensive regulatory information for IVD Quantitative D-Dimer Test Kit in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại B medical device is registered under number 230001943/PCBB-HN and manufactured by Theo theo phụ lục.
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