ETEST® Gentamicin (GM)

GUDID 03573026624453

ETEST® is a manual, quantitative technique for determination of antimicrobial susceptibility of non-fastidious Gram-negative and Gram-positive aerobic bacteria and fastidious bacteria

BIOMERIEUX SA

Antibacterial minimum inhibitory concentration (MIC) IVD Antibacterial minimum inhibitory concentration (MIC) IVD Antibacterial minimum inhibitory concentration (MIC) IVD Antibacterial minimum inhibitory concentration (MIC) IVD Antibacterial minimum inhibitory concentration (MIC) IVD Antibacterial minimum inhibitory concentration (MIC) IVD Antibacterial minimum inhibitory concentration (MIC) IVD Antibacterial minimum inhibitory concentration (MIC) IVD Antibacterial minimum inhibitory concentration (MIC) IVD Antibacterial minimum inhibitory concentration (MIC) IVD Antibacterial minimum inhibitory concentration (MIC) IVD Antibacterial minimum inhibitory concentration (MIC) IVD Antibacterial minimum inhibitory concentration (MIC) IVD Antibacterial minimum inhibitory concentration (MIC) IVD Antibacterial minimum inhibitory concentration (MIC) IVD

• Primary Device ID: 03573026624453
• NIH Device Record Key: 42b6a383-79a5-4f32-83f3-581bb321b4d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ETEST® Gentamicin (GM)
• Version Model Number: ETEST®
• Company DUNS: 276816717
• Company Name: BIOMERIEUX SA
• 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: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03573026624453 [Package]; Contains: 03573026624842; Package: [30 Units]; In Commercial Distribution
GS1	03573026624842 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K913459

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: 2022-12-08
• Device Publish Date: 2022-11-30

On-Brand Devices [ETEST® Gentamicin (GM)]

• 03573026624453: ETEST® is a manual, quantitative technique for determination of antimicrobial susceptibility of
• 03573026256685: Etest is a quantitative technique for determining susceptibility of clinically significant bacte