Liofilchem MTS (MIC Test Strip)

Primary DI
08055182872909
Brand
Liofilchem MTS (MIC Test Strip)
Company
LIOFILCHEM SRL
Model
Eravacycline ERV 0.002-32 µg/mL 10 STRIP
Catalog number
92104-10
Device description
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
Published
2018-11-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
JWYManual Antimicrobial Susceptibility Test Systems

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWYManual Antimicrobial Susceptibility Test SystemsMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182557000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182557000MTS Eravacycline 0.002 - 32 µg/mLLiofilchem s.r.l.2018-11-02JWY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18055182872906PackageGS110In Commercial Distribution
08055182872909PrimaryGS10
08055182872886Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1805518287290618055182872906
08055182872909080551828729098055182872909
08055182872886080551828728868055182872886

GMDN Terms#

Term, Definition table
TermDefinition
Eravacycline minimum inhibitory concentration (MIC) IVDA graduated test strip or collection of reagents containing a specified concentration gradient of the antimicrobial eravacycline, intended to be used to determine the minimum inhibitory concentration (MIC) for a particular microorganism, isolated from a clinical specimen by culture.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius8 Degrees Celsius

Regulatory Flags#

DUNS number
435342134
Device count
10
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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