Duns Number:435342134
Device Description: The Liofilchem® MTS™ (MIC Test Strip) is a quantitative method intended for the in vitro d The Liofilchem® MTS™ (MIC Test Strip) is a quantitative method intended for the in vitro determination ofantimicrobial susceptibility ofbacteria MTS™ consists ofspecialized papyr impregnated with a pre-defined concentration gradient ofan antimicrobial agent, which is used todetermine the minimum inhibitozy concentration (MIC) in µglmL ofantimicrobial agents against bacteria as tested on agar media using ovemightincubation and manual reading procedures. The MTS™ Plazomicin at concentrations of0.016-256 µglmL should be interpreted at 16-20 hours ofincubation.MTS™ PLZ can be used to dete1mine the MIC ofplazomicin against the microorganisms listed below:Plazomicin Activity According to the FDA LabelClinical and in vitroEnterobacter cloacaeEscherichia coliKlebsiella pneumoniaeProteus mirabilisin vitro onlyCitrobacterfreundiiCitrobacter koseriKlebsiella (Enterobacter) aerogenesKlebsiella oxytocaMorganella morganiiProteus vulgarisProvidencia stuartiiSerratia marcescens
Catalog Number
$92070-10
Brand Name
Liofilchem MTS (MIC Test Strip)
Version/Model Number
Plazomicin 0.016-256 µg/mL
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K181708,K181708,K181708
Product Code
JWY
Product Code Name
Manual Antimicrobial Susceptibility Test Systems
Public Device Record Key
361418a9-0803-4b4a-a557-badc18516d69
Public Version Date
October 08, 2018
Public Version Number
1
DI Record Publish Date
September 06, 2018
Package DI Number
18055182872364
Quantity per Package
10
Contains DI Package
08055182872367
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
10
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 25 |