VIDAS® D | 合法醫療器材資訊網

2004年7月23日—bioMérieuxannouncesthatitsD-dimerassay,VIDASD-DimerExclusion,isnowclearedbytheU.S.FoodandDrugAdministration(FDA)to ...

VIDAS® D-Dimer Exclusion™ test from bioMérieux for reliable exclusion of pulmonary embolism and deep vein thrombosis

Marcy lEtoile, France - July 23, 2004. bioMérieux announces that its D-dimer assay, VIDAS D-Dimer Exclusion, is now cleared by the U.S. Food and Drug Administration (FDA) to exclude both pulmonary embolism (PE) and deep vein thrombosis (DVT) as a diagnosis in outpatients. VIDAS D-Dimer Exclusion is the first and only D-dimer assay to be cleared for exclusion of both conditions -- with no further testing -- when used in conjunction with a pre-test probability (PTP) assessment, in low-to-moderate probability outpatients.  

This clearance means that patients who present to the Emergency Department with suspected PE or DVT may no longer be subjected to invasive and costly imaging examinations for a negative diagnosis.

PE and DVT, collectively referred to...