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The MicroScan® Dried Gram-Positive MIC/Combo Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-positive bacteria. After inoculation, panels are incubated for 16 - 20 hours at 35°C +/- 1°C in a non-CO2 incubator, and read either visually or with MicroScan instrumentation, according to the Package Insert. This particular submission is for the addition of the antimicrobial Tigecycline at concentrations of 0.12 - 8 mcg/ml to the test panel. MicroScan® Dried Gram-Positive Tigecycline is a qualitative test. Tigecycline has been shown to be active against the organisms listed below according to the FDA label for the antimicrobial. Active in vitro and in clinical infections: Enterococcus faecalis (vancomycin-susceptible isolates) Staphylococcus aureus (methicillin-susceptible and -resistant isolates) Active in vitro but clinical significance unknown: Staphylococcus epidermidis (methicillin-susceptible and -resistant isolates)

MicroScan Dried Gram-Positive MIC/Combo Panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-positive bacteria. The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in broth and dehydrated. Various antimicrobial agents are diluted in broth to concentrations bridging the range of clinical interest. Panels are rehydrated with water after inoculation with a standardized suspension of the organism. After incubation in a non-CO2 incubator for 16-20 hours, the minimum inhibitory concentration (MIC) for the test organism is read by determining the lowest antimicrobial concentration showing inhibition of growth.

The IMMULITE® Anti-TG Ab Calibration Material (CVM) is for in vitro diagnostic use in the verification of callbration of the IMMULITE Anti-TG Ab assay on the IMMULITE 2000 systems as indicated in the CVM Package Insert. The IMMULITE® Thyroglobulin Calibration Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Thyroglobulin assay on the IMMULITE 2000 systems as indicated in the CVM Package Insert. The IMMULITE® Anti-TPO Ab Calibration Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Anti-TPO Ab assay on the IMMULITE 2000 systems as indicated in the CVM Package Insert.

The Calibration Verification Material (CVM) contains one set of four vials, 2 mL each. LTGCVM i contains human serum/ buffer matrix with preservatives. LTGCVM2, LTGCVM3 and LTGCVM4 contain low, intermediate and high levels of Anti-TG Ab respectively, in human serum/ buffer matrix matrix with preservatives. The Calibration Verification Material (CVM) contains one set of four vials, 2 mL each. LTOCVM1 contains human serum/ buffer matrix with preservatives. LTOCVM2, LTOCVM3 and LTOCVM4 contain low, intermediate and high levels of Anti-TPO Ab respectively, in human serum/ buffer matrix matrix with preservatives. The Calibration Verification Material (CVM) contains one set of four vials, 2 mL each. LTYCVM1 in horse serum matrix with preservatives. LTYCVM2. LTYCVM3 and LTYCVM4 contain low, intermediate and high levels of Thyroglobulin respectively, in horse serum matrix with preservatives.