Liofilchem MTS (MIC Test Strip) - The Liofilchem® MTS™ (MIC Test Strip) - LIOFILCHEM SRL

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

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More Product Details

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

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)

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 Details

Product Code

JWY

Product Code Name

Manual Antimicrobial Susceptibility Test Systems

Device Record Status

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

Additional Identifiers

Package DI Number

18055182872906

Quantity per Package

10

Contains DI Package

08055182872909

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