IVD Department quantitative testing of the fibrin degradation product (D-Dimer and X-oligomer) - Vietnam Registration 2403552ĐKLH/BYT-HTTB
Access comprehensive regulatory information for IVD Department quantitative testing of the fibrin degradation product (D-Dimer and X-oligomer) in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TBYT Loại C medical device is registered under number 2403552ĐKLH/BYT-HTTB. The authorized representative in Vietnam is CÔNG TY TNHH ROCHE VIỆT NAM.
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Device Details
Registration Details
2403552ĐKLH/BYT-HTTB
000.00.04.G18-240825-0001
Theo theo phụ lục
Theo phụ lục
Technical Details
D-DI2: In vitro diagnostic test used to quantitatively measure 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 (<0.5 µg FEUa)/mL) excludes deep vein thrombosis (DVT) and pulmonary embolism (PE) with high sensitivity. a) Equivalent to Fibrinogen. D-Dimer Gen.2 Calibrator Set: D-DimerGen.2Calibrator Set is used to calibrate the quantitative methods of Roche on Roche clinical chemistry analyzers as per the specifications in the attached value document.; D-Dimer Gen.2 Control I/II: D-Dimer Gen.2 ControlI/II is used in quality control to assess the accuracy and precision of the quantitative methods specified in the attached value document.
Dates and Status
Nov 14, 2024