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Liofilchem Mic Test Strip (MTS)

FDA UDI

Class II (US FDA UDI)

by Liofilchem, Inc.

Identity

Trade Name
Liofilchem Mic Test Strip (MTS) FDA UDI
Generic Name
Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit FDA UDI
Device Name
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 bacteria Enterobacter cloacae Escherichia coli Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa Serratia marcescens Levofloxacin has been shown to be active in vitro only against the non-fastidious bacteria listed below according to the FDA drug approved label: Citrobacter freundii Citrobacter koseri Klebsiella aerogenes Klebsiella oxytoca Morganella morganii Proteus vulgaris Providencia rettgeri Providencia stuartii FDA UDI
Model / Reference
Levofloxacin LEV 0.002-32 μg/mL 1 Strip FDA UDI
Description
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 bacteria Enterobacter cloacae Escherichia coli Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa Serratia marcescens Levofloxacin has been shown to be active in vitro only against the non-fastidious bacteria listed below according to the FDA drug approved label: Citrobacter freundii Citrobacter koseri Klebsiella aerogenes Klebsiella oxytoca Morganella morganii Proteus vulgaris Providencia rettgeri Providencia stuartii FDA UDI

Identifiers

Catalog Number
$92081-1 FDA UDI
Primary DI / UDI-DI
08055182872565 FDA UDI
FDA Product Code
JWY FDA UDI
GMDN Term
Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.1640 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit

Liofilchem Mic Test Strip (MTS) by Liofilchem, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Liofilchem, Inc.

Sources (1)

  • FDA UDI 7983972e-0be1-4eec-afdd-f6021e75f607 35 fields · synced Jun 1, 2026