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The VIDAS D-Dimer (DD) Assay is for the quantitative detection of fibrin degradation products (FbDP) in human plasma. It is intended to aid in the diagnosis of deep venous thrombosis and pulmonary embolism disease. The VIDAS D-Dimer (DD) assay is intended for use with a VIDAS (Vitek ImmunoDiagnostic Assay System) instrument as an automated quantitative enzyme-linked fluorescent immunoassay (ELFA) for the determination of fibrin degradation products (FbDP) in plasma (trisodium citrate). The VIDAS D-Dimer assay is intended for use as an aid in the diagnosis of deep venous thrombosis and pulmonary embolism disease.

The VIDAS D-Dimer assay is an enzyme-linked fluorescent immunoassay (ELFA) performed on an automated VIDAS instrument. All assay steps and assay temperature are controlled by the instrument. A pipette tip-like disposable device known as the Solid Phase Receptacle (SPR), serves as a solid phase for the assay as well as a pipetting device. Reagents for the assay are located in the sealed VIDAS DD Reagent Strips. The VIDAS D-Dimer kit contains 60 SPRs, 60 Reagent Strips, 2 Bottles of Calibrator, 2 Bottles each level of Positive Control (three levels) and 1 bottle of Diluent. The Kit contains a sufficient number of SPR's and Strips to perform 60 Tests. The SPR is coated with mouse anti-FbDP antibodies. The Strip contains the reagents necessary to perform the assay, as well as a sample well for placement of the specimen. Each DD test requires one DD Reagent Strip and one DD SPR.

The VIDAS Rotavirus (RTV) Assay is for the qualitative detection of rotavirus antigen in stool specimens. It is intended as an aid in the diagnosis of acute nonbacterial gastroenteritis.

The VIDAS Rotavirus (RTV) Assay is an enzyme-linked fluorescent immunoassay (ELFA) performed in an automated VIDAS (Vitek ImmunoDiagnositic Assay System) instrument. All assay steps and the assay temperature are controlled by the instrument. The VIDAS Rotavirus Assay contains a pipette tip-like disposable device, the Solid Phase Receptacle (SPR), a Reagent Strip, 1 Bottle of Standard, 1 Bottle of Positive Control, and 1 Bottle of Negative Control. The Kit contains a sufficient number of SPR's and Strips to perform 60 Tests. The SPR serves as the solid phase, as well as, the pipettor for the assay. The SPR is coated with rabbit anti-rotavirus antibodies. The Strip contains the reagents necessary to perform the assay, as well as, a sample well for placement of the specimen. Each RTV Assay requires one RTV Reagent Strip and one RTV SPR.

The VIDAS Rotavirus (RTV) Assay detects the presence of rotavirus antigen in stool specimens.

The VIDAS RTV Assay detects the presence of rotavirus antigen in stool specimens. Assay specificity is conferred by the use of two antibodies. The rotavirus antigen is captured on the SPR by a polyclonal anti-rotavirus VP6 antibody, and the detector antibody conjugate is composed of a mouse monoclonal anti-rotavirus VP6 antibody.

The VIDAS C. difficile Toxin A II assay detects the presence of C. difficile toxin A. It is substantially equivalent to the Meridian Premier C. difficile Toxin A test as an aid in the diagnosis of Clostridium difficile associated disease (CDAD).

The VIDAS C. difficile Toxin A II assay detects the presence of C. difficile toxin A.

used as a supplemental test to verify positive and equivocal results from female endocervical and male urtheral specimens in the VIDAS Chlamydia (CHL) assay and is substantially equivalent to cell culture for the qualitative detection of Chlamydia antigen.

The VIDAS Chlamydia Blocking assay is a fully automated enzyme-linked fluorescent immunoassay (ELFA) and requires only the addition of the blocking and reference reagents to the VIDAS Chlamydia strips.

The VIDAS CKMB assay determines the concentration of creatine kinase MB isoenzyme in serum or plasma (heparin or EDTA).

The VIDAS CKMB assay determines the concentration of creatine kinase MB isoenzyme in serum or plasma (heparin or EDTA). It is substantially equivalent to the Ciba-Corning Magic Lite CK-MB assay.

The Vitek GNI+ Card is intended to be used in conjunction with the Vitek System for the automated identification of microorganism of the family Enterobacteriaceae. In addition, a select group of glucose non-fermenting gram-negative bacteria, and members of the family Vibrionaceae can be identified. In addition to the organisms currently claimed with the GNI Card, the GNI+ Card has added the following 13 new organism claims: - Aeromanas veronii biovar veronii Budvicia aquatica Burkholdenia mallei CDC Group EO-2 Chromobacterium violaceum Edwardsiella hoshinae Klebsiella ornithinolytica Moellerella wisconsensis Rahnella aquatilis Shigella boydii/flexneri Sphingobacterium spiritivorum Sphingobacterium thalpophilum Yokenella regensburgei (Koserella trabulsii)

The GNI+ Card consists of a plastic card with thirty wells that contain 28 dehydrated biochemical broths, one negative control broth and one growth control broth. The broths are re-hydrated with a saline suspension of a pure culture isolated from a patient specimen. The GNI+ Card performs a variety of conventional and non-conventional biochemical tests that are based on established biochemical methods. Organism identification usually requires between 2-12 hours of incubation on the automated Vitek System.

is intended for use in conjunction with the Vitek® System for the automated identification of clinically significant streptococci, staphylococci, and a selected group of Gram positive bacilli.

The VITEK® Gram Positive Identification Card containing new claims for the identification of Enterococcus casseliflavus Enterococcus gallinarum Enterococcus hirae