Search Results

The Thermo Scientific Sensititre ARIS HiQ System is part of the Sensititre AST system and is an automated plate management device containing an incubator and embedded OptiRead module. The Thermo Scientific Sensititre ARIS HiQ System is designed for use with the Thermo Scientific Sensititre SWIN Software System. The ARIS HiQ and the SWIN system work together to read Sensititre (18-24 hr) susceptibility plates, generating minimum inhibitory concentration (MIC) and interpreting breakpoint (BP) results for non-fastidious microorganisms.

The Thermo Scientific Sensititre ARIS HiQ System is part of the Sensititre AST system and is an automated plate management device containing an incubator and embedded OptiRead module. The Thermo Scientific Sensititre ARIS HiQ System is designed for use with the Thermo Scientific Sensititre SWIN Software System. The ARIS HiQ and the SWIN system work together to read Sensititre (18-24 hr) susceptibility plates, generating minimum inhibitory concentration (MIC) and interpreting breakpoint (BP) results for non-fastidious microorganisms.

The Thermo Scientific Sensititre ARIS HiQ System is part of the Sensititre AST system and is an automated plate management device containing an incubator and embedded OptiRead module. The Thermo Scientific Sensititire ARIS HiO System is designed for use with the Themo Scientific Sensitities SWIN Software System. The ARIS HiQ and the SWIN system work together to read Sensititre (18-24 hr) susceptibility plates, generating minimum inhibitory concentration (MIC) and interpreting breakpoint (BP) results for non-fastidious microorganisms.

The Thermo Scientific Sensititre ARIS HiQ System is part of the Sensititre AST system and is an automated plate management device containing an incubator and embedded OptiRead module. The Thermo Scientific Sensititire ARIS HiO System is designed for use with the Themo Scientific Sensitities SWIN Software System. The ARIS HiQ and the SWIN system work together to read Sensititre (18-24 hr) susceptibility plates, generating minimum inhibitory concentration (MIC) and interpreting breakpoint (BP) results for non-fastidious microorganisms.

The Sensititre® OptiRead™ is intended for use with the Sensititre® MIC or BP Susceptibility Test System. The Sensititre® OptiRead™ is a fluorescence based detection instrument used to read Sensititre® MIC or BP Susceptibility plates. The Sensititre MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non-fastidious Gram negative organisms. The Sensititre OptiRead is used to read fluorescence values from the Sensititre MIC or BP Susceptibility Test System for non-fastidious Gram negative organisms. The plate reading on the OptiRead is initiated via SWIN software and the fluorescence values from the OptiRead are then transferred back to the SWIN software where the results are generated.

The Sensititre® OptiRead™ is a fluorescence based detection instrument used to read Sensititre® MIC or BP Susceptibility plates.

The Sensititre® OptiRead™ is intended for use with the Sensititre® MIC or BP Susceptibility Test System. The Sensititre® OptiRead™ is a fluorescence based detection instrument used to read Sensititre® MIC or BP Susceptibility plates. The Sensititre MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non-fastidious Gram positive cocci to include Staphylococcus spp., Enterococcus spp., Streptococcus pneumoniae and, other Streptococcus spp. This 510(k) is for the addition of: "Sensititre® OptiRead™" The Sensititre OptiRead is used to read fluorescence values from the Sensititre MIC or BP Susceptibility Test System for non-fastidious and fastidious Gram positive cocci. The plate reading on the OptiRead is initiated via SWIN software and the fluorescence values from the OptiRead are then transferred back to the SWIN software where the results are generated.

The Sensititre® OptiRead™ is a fluorescence based detection instrument used to read Sensititre® MIC or BP Susceptibility plates.

The MicroScan® MICroSTREP plus® Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci including Streptococcus pneumoniae. After inoculation, panels are incubated for 20 -24 hours at 35°C +/- 1°C in a non-CO2 incubator, and read visually. Alternatively, the panels can be incubated in and read by the MicroScan® WalkAway System, according to the Package insert. This particular submission is for the addition of the antimicrobial agent Linezolid, at concentrations of 0.12 to 16 ug/mL, to the test panel. The organisms which may be used for Linezolid susceptibility testing in this panel are: Streptococcus pneumoniae including multi-drug resistant strains Streptococcus pyogenes Streptococcus agalactiae Viridans group streptococci

MicroScan MICroSTREP plus panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of . aerobic streptococci, including Streptococcus pneumoniae. The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in water and dehydrated. Various antimicrobial agents are diluted in water, buffer or minute concentrations of broth to concentrations bridging the range of clinical interest. Panels are rehydrated with 115 µl Mueller-Hinton broth supplemented with 2-5% lysed horse blood (LHB), after inoculation of the broth with a standardized suspension of the organism. After incubation in a non-CO2 incubator for 20-24 hours, the minimum inhibitory concentration (MIC) for the test organism is manually read by observing the lowest antimicrobial concentration showing inhibition of growth. Alternatively, the panel can be incubated in and read by the MicroScan® WalkAway System.

The MicroScan® MICroSTREP plus® Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae. After inoculation, panels are incubated for 20 - 24 hours at 35°C +/- 1°C in a non-CO2 incubator, and read visually. Alternatively, the panels can be incubated in and read by the MicroScan® WalkAway System, according to the Package Insert. This particular submission is for the addition of the antimicrobial Moxifloxacin at concentrations of 0.03 to 8 ug/ml to the test panel. The organisms which may be used for Moxifloxacin susceptibility testing in this panel are: Streptococcus pneumoniae (including penicillin resistant strains) Streptococcus pyogenes Streptoccocus agalactiae Streptococcus constellatus Streptococcus anginosus Viridans group streptococci

MicroScan MICroSTREP plus panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae. The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in water and dehydrated. Various antimicrobial agents are diluted in water, buffer or minute concentrations of broth to concentrations bridging the range of clinical interest. Panels are rehydrated with 115 µl Mueller-Hinton broth supplemented with 2-5% lysed horse blood (LHB), after inoculation of the broth with a standardized suspension of the organism. After incubation in a non-CO2 incubator for 20-24 hours, the minimum inhibitory concentration (MIC) for the test organism is manually read by observing the lowest antimicrobial concentration showing inhibition of growth. Alternatively, the panel can be incubated in and read by the MicroScan® WalkAway System.

The MicroScan® Dried Gram-Negative 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-negative bacilli. 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 Doripenem at concentrations of 0.008 to 32 mcg/ml to the test panel. The gram-negative organisms which may be used for Doripenem susceptibility testing in this panel are: Acinetobacter baumanii Escherichia coli Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa

MicroScan Dried Gram-Negative 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-negative bacilli. 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 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 cocci. After inoculation, panels are incubated for 16 - 24 hours at 35℃ +/- 1℃ in a non-CO2 incubator, and read either visually or with MicroScan instrumentation, according to the Package Insert. The MicroScan Cefoxitin Screen is intended to determine the susceptibility of staphylococci to the penicillinase stable beta-lactams. This particular submission is for the addition of the antimicrobial test the Cefoxitin Screen, at a concentration of 4 mcg/ml, to the test panel. The gram-positive organisms which may be used for Cefoxitin Screen susceptibility testing in this panel are: Staphylococcus aureus Staphylococcus lugdunensis

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 cocci. 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 MicroScan® Synergies plus™ 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 enterococci and staphylococci. After inoculation, panels are incubated for 4.5 - 18 hours at 35℃ +/- 1℃, in a WalkAway® SI, or equivalent, and read by the MicroScan® Instrumentation. Additionally, the panels may be incubated in a non-CO2 incubator and the Antimicrobial Susceptibility Testing (AST) portions can be read visually, according to the Package Insert. This particular submission is for the addition of the antimicrobial Streptomycin Synergy Screen, at a concentration of 1000 ug/ml, for enterococci, to the test panel. The gram-positive organisms which may be used for Streptomycin Synergy Screen susceptibility testing in this panel are: Enterococcus species

MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels, utilizing both the MicroScan® Rapid Fluorogenic Identification and Dried Overnight Antimicrobial Susceptibility Testing (AST) technologies, 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 enterococci and staphylococci. The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in water and dehydrated. Various antimicrobial agents are diluted in water, buffer, or minute concentrations of broth, to concentrations bridging the range of clinical interest. Panels are rehydrated with Synergies plus"" Pos Broth, after inoculation with a standardized suspension of the organism. After incubation in the WalkAway® SI, or equivalent, System, for 4.5 -18 hours, the minimum inhibitory concentration (MIC) for the test organism is read by determining the lowest antimicrobial concentration showing inhibition of growth.

To determine bacterial antimicrobial agent susceptibility The MicroScan MICroSTREP plus® Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae. After inoculation, panels are incubated for 20 - 24 hours at 35℃ +/- 1℃ in a non-CO2 incubator, and read visually according to the Package Insert. Additionally, the panels may be incubated in and read by a MicroScan® WalkAway instrument. This particular submission is for the addition of instrument read capability of the antimicrobial Clarithromycin, at concentrations of 0.06 - 2 mcg/ml on the MicroScan MICroSTREP plus® Panel. The organisms which may be used for Clarithromycin susceptibility testing on this panel are: Streptococcus pneumoniae Streptococcus pyogenes Streptococcus agalactiae Streptococci (Groups C, F, G) viridans group streptococci

The MicroScan MICroSTREP plus® Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae. After inoculation, panels are incubated for 20 – 24 hours at 35°C +/-1 ℃ in a non-CO2 incubator, and read according to the Package Insert. The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test. Various antimicrobial agents are diluted in water, buffer or minute concentrations of broth to concentrations bridging the range of clinical interest. Panels are rehydrated with 115 µl Mueller-Hinton broth supplemented with 2-5% lysed horse blood (LHB) and buffered with 50 mM HEPES, after inoculation of the broth with a standardized suspension of the organism in saline. After incubation in a non-CO2 incubator for 20-24 hours, the minimum inhibitory concentration (MIC) for the test organism is manually read by observing the lowest antimicrobial concentration showing inhibition of growth. Additionally, the panels may be incubated in and read by a MicroScan® WalkAway instrument.