Liofilchem Mic Test Strip (MTS) $92045-10

GUDID 18055182871701

The MTS™ (MIC Test Strip) Ciprofloxacin 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. The MTS™ Ciprofloxacin at concentrations of 0.002-32 μg/mL should be interpreted at 16-20 hours of incubation. MTS™ Ciprofloxacin can be used to determine the MIC of ciprofloxacin against the following bacteria. Ciprofloxacin 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 Citrobacter freundii Citrobacter koseri Enterobacter cloacae Escherichia coli Klebsiella pneumoniae Morganella morganii Proteus mirabilis Proteus vulgaris Providencia rettgeri Providencia stuartii Pseudomonas aeruginosa Serratia marcescens

LIOFILCHEM SRL

Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit

• Primary Device ID: 18055182871701
• NIH Device Record Key: 866b559c-02f1-4909-a394-8486f2a7ac68
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Liofilchem Mic Test Strip (MTS)
• Version Model Number: Ciprofloxacin CIP 0.002-32 μg/mL 10 Strips
• Catalog Number: $92045-10
• Company DUNS: 435342134
• Company Name: LIOFILCHEM SRL
• Device Count: 10
• 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	08055182871681 [Unit of Use]
GS1	08055182871704 [Primary]
GS1	18055182871701 [Package]; Contains: 08055182871704; Package: box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183527

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

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