Liofilchem MIC Test Strip (MTS) $92068-1

GUDID 28055182872293

LIOFILCHEM SRL

Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit

• Primary Device ID: 28055182872293
• NIH Device Record Key: 15f4debb-fcb6-4693-9dcc-e2e116f20f70
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Liofilchem MIC Test Strip (MTS)
• Version Model Number: Imipenem IMI 0.016-256 µg/ml, 1 Strip
• Catalog Number: $92068-1
• 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 0 Degrees Celsius and -20 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08055182872299 [Primary]
GS1	18055182872296 [Package]; Contains: 08055182872299; Package: box [10 Units]; In Commercial Distribution
GS1	28055182872293 [Package]; Contains: 08055182872299; Package: box [30 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191908

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: 2019-09-24
• Device Publish Date: 2019-09-16

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• 18055182871701: The MTS™ (MIC Test Strip) Ciprofloxacin 0.002-32 μg/mL is a quantitative method intended for
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• 18055182872302: Imipenem IMI 0.016-256 µg/ml 10 Strip
• 28055182872293: Imipenem IMI 0.016-256 µg/ml, 1 Strip
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• 28055182871159: Ampicillin*-sulbactam (2/1) AMS 0.016-256*
• 18055182872388: Omadacycline 0.002-32 µg/mL, 1 Strip