Liofilchem Mic Test Strip (MTS) $92081-1

GUDID 28055182872569

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

LIOFILCHEM SRL

Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit

• Primary Device ID: 28055182872569
• NIH Device Record Key: 7983972e-0be1-4eec-afdd-f6021e75f607
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Liofilchem Mic Test Strip (MTS)
• Version Model Number: Levofloxacin LEV 0.002-32 μg/mL 1 Strip
• Catalog Number: $92081-1
• Company DUNS: 435342134
• Company Name: LIOFILCHEM SRL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08055182872565 [Primary]
GS1	18055182872562 [Package]; Contains: 08055182872565; Package: [10 Units]; In Commercial Distribution
GS1	28055182872569 [Package]; Contains: 08055182872565; Package: box [30 Units]; In Commercial Distribution

FDA Product Code

• JWY: Manual Antimicrobial Susceptibility Test Systems

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-29
• Device Publish Date: 2019-04-19

On-Brand Devices [Liofilchem Mic Test Strip (MTS)]

• 18055182872579: MTS™ (MIC Test Strip) Levofloxacin 0.002-32 μg/mL is a quantitative method intended for the i
• 28055182872569: MTS™ (MIC Test Strip) Levofloxacin 0.002-32 μg/mL is a quantitative method intended for the i
• 18055182871701: The MTS™ (MIC Test Strip) Ciprofloxacin 0.002-32 μg/mL is a quantitative method intended for
• 28055182871692: The MTS™ (MIC Test Strip) Ciprofloxacin 0.002-32 μg/mL is a quantitative method intended for
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• 18055182871169: Ampicillin*-sulbactam (2/1) AMS 0.016-256*
• 28055182871159: Ampicillin*-sulbactam (2/1) AMS 0.016-256*
• 18055182872388: Omadacycline 0.002-32 µg/mL, 1 Strip