Liofilchem Mic Test Strip (MTS) - MTS™ (MIC Test Strip) Levofloxacin 0.002-32 μg/mL - LIOFILCHEM SRL

Duns Number:435342134

Device Description: MTS™ (MIC Test Strip) Levofloxacin 0.002-32 μg/mL is a quantitative method intended for th MTS™ (MIC Test Strip) Levofloxacin 0.002-32 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 of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures.MTS™ Levofloxacin at concentrations of 0.002-32 μg/mL should be interpreted at 16-20 hours of incubation.MTS™ Levofloxacin can be used to determine the MIC of levofloxacin against the following bacteria.Levofloxacin has been shown to be active both clinically and in vitro against these bacterial species according to the FDA drug approved label:Gram-negative bacteriaEnterobacter cloacaeEscherichia coliKlebsiella pneumoniaeProteus mirabilisPseudomonas aeruginosaSerratia marcescensLevofloxacin has been shown to be active in vitro only against the non-fastidious bacteria listed below according to the FDA drug approved label:Citrobacter freundiiCitrobacter koseriKlebsiella aerogenesKlebsiella oxytocaMorganella morganiiProteus vulgarisProvidencia rettgeriProvidencia stuartii

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More Product Details

Catalog Number

$92081-1

Brand Name

Liofilchem Mic Test Strip (MTS)

Version/Model Number

Levofloxacin LEV 0.002-32 μg/mL 1 Strip

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

JWY

Product Code Name

Manual Antimicrobial Susceptibility Test Systems

Device Record Status

Public Device Record Key

7983972e-0be1-4eec-afdd-f6021e75f607

Public Version Date

April 29, 2019

Public Version Number

1

DI Record Publish Date

April 19, 2019

Additional Identifiers

Package DI Number

28055182872569

Quantity per Package

30

Contains DI Package

08055182872565

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box

"LIOFILCHEM SRL" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 25