Duns Number:435342134
Device Description: The Liofilchem® MTS™ (MIC Test Strip) Eravacycline 0.002-32 µg/mL is a quantitative method The Liofilchem® MTS™ (MIC Test Strip) Eravacycline 0.002-32 µg/mL is a quantitative method intended for the in vitro determination of antimicrobial susceptibility ofbacteria. MTS™ consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used todetermine the minimum inhibitory concentration (MIC) in µglmL of antimicrobial agents against bacteria as tested on agar media using ovemightincubation and manual reading procedures. The MTS™ Eravacycline at concentrations of 0.002-32 µglmL should be interpreted at 16-20 hours ofincubation.MTS™ Eravacycline can be used to dete1mine the MIC of eravacycline against the following bacteria.Eravacycline has been shown to be active both clinically and in vitro against these bacterial species accoring to the FDA drug approved label:Gram-positive bacteriaEnterococcus faecalisEnterococcus faeciumStaphylococcus aureusGram-negative bacteriaCitrobacter freundiiEnterobacter cloacaeEscherichia coliKlebsiella oxytocaKlebsiella pneumoniaeEravacycline has been shown to be active in vitro only against the non-fastidious bacteria listed below accoring to the FDA drug aprroved label:Citrobacter koseriKlebsiella (Enterobacter) aerogenes
Catalog Number
92104-10
Brand Name
Liofilchem MTS (MIC Test Strip)
Version/Model Number
Eravacycline ERV 0.002-32 µg/mL 10 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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K182557,K182557,K182557
Product Code
JWY
Product Code Name
Manual Antimicrobial Susceptibility Test Systems
Public Device Record Key
3e1849ec-c99d-4704-9bba-7e85e83ac7d4
Public Version Date
December 10, 2018
Public Version Number
1
DI Record Publish Date
November 09, 2018
Package DI Number
18055182872906
Quantity per Package
10
Contains DI Package
08055182872909
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 |