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
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
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
JWY
Product Code Name
Manual Antimicrobial Susceptibility Test Systems
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
Package DI Number
28055182872569
Quantity per Package
30
Contains DI Package
08055182872565
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 25 |