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The ComASP® Cefiderocol 0.008-128 is a quantitative broth microdilution method intended for the in vitro determination of antimicrobial susceptibility of bacteria. ComASP® Cefiderocol consists of polystyrene microtier panels containing lyophilized concentrations of cefiderocol and tubes of media (iron depleted cation adjusted Mueller Hinton broth), which are used to determine the minimum inhibitory concentration (MIC) in ug/mL using over overnight incubation and manual reading procedures. ComASP® Cefiderocol at concentrations of 0.008-128 ug/mL should be interpreted at 16-20 hours of incubation. ComASP® Cefiderocol can be used to determine the MC of cefiderocol against the following microorganisms for which cefiderocol has been shown to be active clinically and in vitro according to the FDA drug approved label: Acinetobacter baumannii complex Escherichia coli Enterobacter cloacae complex Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa Serratia marcescens

The ComASP® Cefiderocol 0.008-128 is a quantitative broth microdilution method intended for the in vitro determination of antimicrobial susceptibility of bacteria. ComASP® Cefiderocol consists of polystyrene microtier panels containing lyophilized concentrations of cefiderocol and tubes of media (iron depleted cation adjusted Mueller Hinton broth), which are used to determine the minimum inhibitory concentration (MIC) in ug/mL using over overnight incubation and manual reading procedures.

MTS (MIC Test Strip) Imipenem 0.016 - 256 µg/mL is a quantitative method intended for the in vitro determination of antimicrobial susceptibility of bacteria. MTS consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MIC) in µg/mL against bacteria as tested on agar media using overnight incubation and manual reading procedures. MTS Imipenem at concentrations of 0.016 - 256 µg/mL should be interpreted at 16-20 hours of incubation. Imipenem has been shown to be active both clinically and in vitro against these bacterial species according to the FDA drug approved label: Gram-negative bacteria Citrobacter koseri Citrobacter freundii Enterobacter asburiae Enterobacter cloacae Escherichia coli Klebsiella aerogenes Klebsiella oxytoca Klebsiella pneumoniae Morganella morganii Proteus vulgaris Providencia rettgeri Serratia marcescens Acinetobacter baumannii Pseudomonas aeruginosa Imipenem has been shown to be active in vitro only against the non-fastidious bacteria listed below according to the FDA drug approved label: Gram-negative bacteria Providencia stuartii

MTS (MIC Test Strip) Imipenem 0.016 - 256 µg/mL is a quantitative method intended for the in vitro determination of antimicrobial susceptibility of bacteria. MTS consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MIC) in µg/mL against bacteria as tested on agar media using overnight incubation and manual reading procedures.

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The Liofilchem® MIC Test Strip (MTS) is a quantitative method intended for the in vitro determination of antimicrobial susceptibility of bacteria. MTS consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MIC) in ug/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures. The Clindamycin MTS at concentrations of 0.016-256 ug/mL should be interpreted at 16-20 hours of incubation. The non-fastidious bacteria that have been shown to be active both clinically and in vitro against Clindamycin according to the FDA label are: Staphylococcus aureus (methicillin-susceptible strains)

MTS consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent.

The Liofilchem® MIC Test Strip (MTS) is a quantitative method intended for the in vitro determination of antimicrobial susceptibility of non-fastidious Gram negative and Gram positive aerobic bacteria (for example, Enterobacteriaceae, Pseudomonas, Enterococcus and Staphylococus species) and fastidious bacteria (for example, anaerobes, Haemophilus and Streptococcus species and N. gonorrhoeae). MTS consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MCC) in ug/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures. The Telavancin MTS at concentrations of 0.016 - 256 µg/mL should be interpreted at 16-20 hours of incubation. The non-fastidious bacteria that have been shown to be active both clinically and in vitro against Telavancin according to the FDA label are: Staphylococcus aureus (including methicillin-resistant isolates) Enterococcus faecalis (vancomycin-susceptible isolates only)

MTS consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MCC) in ug/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures.

The Liofilchem® MIC Test Strip (MTS) is a quantitative method intended for the in vitro determination of antimicrobial susceptibility of non-fastidious Gram negative and Gram positive aerobic bacteria (for example, Enterobacteriaceae, Pseudomonas, Enterococcus and Staphylococus species) and fastidious bacteria (for example, anaerobes, Haemophilus and Streptococcus species and N. gonorthoeae). MTS consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MIC) in ug/mL of antimicrobial agents against . teria as tested on agar media using overnight incubation and manual reading procedures. The indications for use of this 510(k) is specifically for the Meropenen MTS at concentrations of 0.002-32 ug/mL. The non-fastidious bacteria that have been shown to be active both clinically and in vitro against meropenem according to the FDA label are: Escherichia coli Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa

MTS consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MIC) in ug/mL of antimicrobial agents against . teria as tested on agar media using overnight incubation and manual reading procedures.

The Liofilchem MIC Test Strip (MTS) is a quantitative method intended for the in vitro determination of antimicrobial susceptibility of non-fastidious Gram negative and Gram positive aerobic bacteria (for example, Enterobacteriaceae, Pseudomonas, Enterococcus and Staphylococus species) and fastidious bacteria (for example, anaerobes, Haemophilus and Streptococcus species and N. gonorhoeae). MTS consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MIC) in ug/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures. The purpose of this 510(k) is specifically for the ceftolozane/tazobactam MTS at concentrations of 0.016/4 - 256/4 mcg/mL. Ceftolozane/azobactam has been shown to be active against the following bacteria, both clinically and in vitro according to the FDA label: Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa

MTS consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MIC) in ug/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures.

The Liofilchem MIC Test Strip (MTS) is a quantitative method intended for the in vitro determination of antimicrobial susceptibility of non-fastidious Gram negative and Gram positive aerobic bacteria (for example, Enterobacteriaceae, Pseudomonas, Enterococcus and Staphylococus species) and fastidious bacteria (for example, anaerobes, Haemophilus and Streptococcus species and N. gonorthoeae). MTS consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MIC) in up/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures. The purpose of the 510(k) is specifically for the dalbavancin MTS at concentrations of 0.002-32 ug/mL interpreted after 16-20 hours incubation. Dalbavancin has been shown to be active against the following bacteria, both clinically and in vitro according to the FDA label: Staphylococcus aureus (including methicillin resistant strains) Enterococcus faecalis (vancomycin susceptible strains)

MTS consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MIC) in up/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures.

The Liofilchem MIC Test Strip (MTS) is a quantitative method intended for the in vitro determination of antimicrobial suscretibility of non-fastidious Gram negative and Gram positive aerobic bacteria (for example. Enterobacteriaceae, Pseudomonas, Enterococcus and Staphylococus species) and fastidious bacteria (for example, Haemophilus and Streptococcus species and N. gonorrhoeae). MTS consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MC) in up/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures. The purpose of this 510(k) is specifically for the vancomycin MTS at concentrations of 0.016 - 256 us/mL interpreted after 24 hours incubation. The non-fastidious bacteria that have been shown to be active both clinically and in vitro against vancomycin according to the FDA label are: Staphylococcus aureus and Staphylococcus epidermis (including methicillin resistant strains) Enterococcus faecalis Enterococcus faecium

MTS consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MC) in up/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures.