Liofilchem MIC Test Strip $92156-01

GUDID 28055182873825

LIOFILCHEM SRL

Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit

• Primary Device ID: 28055182873825
• NIH Device Record Key: 8f42c2f3-ffba-477c-91a2-322115eac48e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Liofilchem MIC Test Strip
• Version Model Number: Doxycycline DXT 0.016-256
• Catalog Number: $92156-01
• 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 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08055182873821 [Primary]
GS1	18055182873828 [Package]; Contains: 08055182873821; Package: box [10 Units]; In Commercial Distribution
GS1	28055182873825 [Package]; Contains: 08055182873821; Package: box [30 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190914

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: 2019-09-20
• Device Publish Date: 2019-09-12

On-Brand Devices [Liofilchem MIC Test Strip]

• 18055182873835: Doxycycline DXT 0.016-256
• 28055182873825: Doxycycline DXT 0.016-256