IVD Quantitative D-Dimer Test Kit - Vietnam Registration 230001943/PCBB-HN
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.
This page provides complete technical specifications, regulatory compliance details, 2 companies making similar products including Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH, Theo phụ lục, and 2 recent registrations in the same category. Pure Global AI offers free access to 300,000+ Vietnamese medical device registrations, helping global MedTech companies navigate Vietnam MOH regulations, identify competitors, and discover partnership opportunities efficiently.
Device Details
Registration Details
230001943/PCBB-HN
000.00.19.H26-230731-0003
Theo theo phụ lục
Theo phụ lục
Technical Details
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.
Dates and Status
Aug 16, 2023