Etest® ESBL CT/CTL 16/1

GUDID 03573026256753

Etest is a quantitative technique for determining the MIC of antimicrobial agents against microorganisms and for detection of resistance mechanisms.

BIOMERIEUX SA

Antibacterial minimum inhibitory concentration (MIC) IVD

• Primary Device ID: 03573026256753
• NIH Device Record Key: 0d2d41fa-a272-4712-9c9b-21baac4dadf2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Etest® ESBL CT/CTL 16/1
• Version Model Number: Etest® ESBL CT/CTL 16/1
• 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
• Storage Environment Temperature: Between -20 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -20 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	03573026256753 [Package]; Contains: 03573026548094; Package: [10 Units]; In Commercial Distribution
GS1	03573026256982 [Package]; Contains: 03573026548100; Package: [10 Units]; In Commercial Distribution
GS1	03573026547257 [Primary]
GS1	03573026548094 [Package]; Contains: 03573026547257; Package: [3 Units]; In Commercial Distribution
GS1	03573026548100 [Package]; Contains: 03573026547257; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K001547

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: 5
• Public Version Date: 2019-11-01
• Device Publish Date: 2016-11-18

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