Etest® ITRACONAZOLE

GUDID 03573026616014

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

BIOMERIEUX SA

Antifungal minimum inhibitory concentration (MIC) IVD Antifungal minimum inhibitory concentration (MIC) IVD Antifungal minimum inhibitory concentration (MIC) IVD Antifungal minimum inhibitory concentration (MIC) IVD Antifungal minimum inhibitory concentration (MIC) IVD Antifungal minimum inhibitory concentration (MIC) IVD Antifungal minimum inhibitory concentration (MIC) IVD Antifungal minimum inhibitory concentration (MIC) IVD

• Primary Device ID: 03573026616014
• NIH Device Record Key: 89fd8ba0-4b8d-4056-b33a-f1cf33a69e7e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Etest® ITRACONAZOLE
• Version Model Number: Etest® ITRACONAZOLE
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03573026550363 [Primary]
GS1	03573026616014 [Package]; Contains: 03573026550363; Package: [30 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040560

FDA Product Code

• NGZ: Susceptibility test plate, antifungal

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: 2019-10-30
• Device Publish Date: 2019-10-22

On-Brand Devices [Etest® ITRACONAZOLE]

• 03573026616014: Etest is a quantitative technique for determining susceptibility of clinically significant yeast
• 03573026253318: Etest is a quantitative technique for determining susceptibility of clinically significant yeast