Etest® ERTAPENEM

GUDID 03573026260439

Etest is a quantitative technique for determining susceptibility of clinically significant bacteria. It provides a gradient of 15 doubling dilutions for MIC determination.

BIOMERIEUX SA

Antibacterial minimum inhibitory concentration (MIC) IVD

• Primary Device ID: 03573026260439
• NIH Device Record Key: 19ff5f16-3e3e-44bd-920a-c63e88e4bfd5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Etest® ERTAPENEM
• Version Model Number: Etest® ERTAPENEM
• 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 -20 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	03573026260439 [Package]; Contains: 03573026548049; Package: [10 Units]; In Commercial Distribution
GS1	03573026547226 [Primary]
GS1	03573026548049 [Package]; Contains: 03573026547226; Package: [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020748

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-10-30
• Device Publish Date: 2016-11-18

On-Brand Devices [Etest® ERTAPENEM]

• 03573026377533: Etest is a quantitative technique for determining susceptibility of clinically significant bacte
• 03573026260439: Etest is a quantitative technique for determining susceptibility of clinically significant bacte