For in vitro diagnostic use. Others LumiraDx D-Dimer IVD LumiraDx D-Dimer PID00000892 10 418 087 001 10418087001 LumiraDx D-Dimer Test (12T) ML01 LumiraDx D-Dimer Test (12T) ML01 05060537711461 Reagents, kits L005000101012 12 tests Not Available undefined The LumiraDx D-Dimer test is a rapid microfluidic immunofluorescence assay for use with the LumiraDx Instrument for the quantitative measurement of D-Dimer in human whole blood (capillary finger stick and sodium citrated-venous) and sodium citrated-plasma specimens. The test procedure involves the addition of fingerstick, venous whole blood or plasma sample to the sample application area of the Test Strip inserted in the Instrument. The Test Strip is inserted into the Instrument which is programmed to perform the analysis when the sample has reacted with the reagents. The analysis is based on the amount of fluorescence the Instrument detects within the measurement area of the Test Strip. The concentration of the analyte in the sample is proportional to the fluorescence detected. The results are displayed on the Instrument touch-screen in approximately 6 minutes from the addition of sample. en The LumiraDx D-Dimer test is an in vitro diagnostic test for the quantitative determination of D-Dimer in human capillary and venous whole blood and plasma samples (Sodium Citrate). The LumiraDx D-Dimer Test Strips are intended for use with the LumiraDx Instrument. It is an automated in vitro diagnostic test for near-patient testing to aid in the assessment and diagnosis of patients with suspected venous thromboembolism (VTE) such as deep vein thrombosis (DVT) and pulmonary embolism (PE). The test can be used in conjunction with a clinical pre-test probability assessment model to exclude deep vein thrombosis (DVT) and pulmonary embolism (PE) disease in patients suspected of DVT or PE. The LumiraDx D-Dimer test is for Professional Use Only. For patients ≥18 years of age. en

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