Quantitative Test for Fibrin Degradation Products (D-Dimer and X-Oligomer) - Vietnam Registration 2403566ĐKLH/BYT-HTTB
Access comprehensive regulatory information for Quantitative Test for Fibrin Degradation Products (D-Dimer and X-Oligomer) 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 2403566ĐKLH/BYT-HTTB and manufactured by Roche Diagnostics GmbH. The authorized representative in Vietnam is CÔNG TY TNHH ROCHE VIỆT NAM.
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Device Details
Registration Details
2403566ĐKLH/BYT-HTTB
000.00.04.G18-240814-0008
D-DI2
05172381190
Technical Details
In vitro testing used to quantify the degradation products of fibrin (D-Dimer and X-oligomer) in human blood plasma on cobas systems. Combined with the clinical evaluation of low probability, a normal result (<0.5µg FEUa)/mL) excludes deep vein thrombosis (DVT) and pulmonary embolism (PE) with high sensitivity. a) Equivalent units of Fibrinogen
Dates and Status
Nov 14, 2024