Etest® ITRACONAZOLE

GUDID 03573026253318

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

• Primary Device ID: 03573026253318
• NIH Device Record Key: af55a4c4-5de6-48e7-b573-b0f2c2bfb024
• 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 22 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 22 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	03573026253318 [Package]; Contains: 03573026549091; Package: [100 Units]; In Commercial Distribution
GS1	03573026549091 [Primary]

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-11-05
• Device Publish Date: 2016-11-18

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