ETEST®

GUDID 03573026619855

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

• Primary Device ID: 03573026619855
• NIH Device Record Key: 1f352487-a5cc-4c2a-87e2-14203f852bfc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ETEST®
• Version Model Number: ETEST®
• Company DUNS: 276816717
• Company Name: BIOMERIEUX SA
• Device Count: 10
• 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 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	03573026619855 [Package]; Contains: 03573026620233; Package: [10 Units]; In Commercial Distribution
GS1	03573026620233 [Primary]
GS1	03573026620639 [Unit of Use]

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: 2021-11-11
• Device Publish Date: 2021-11-03

On-Brand Devices [ETEST®]

• 03573026618933: ETEST® is a manual, quantitative technique for determination of antimicrobial susceptibility of
• 03573026618780: ETEST® is a manual, quantitative technique for determination of antimicrobial susceptibility of
• 03573026618766: ETEST® is a manual, quantitative technique for determination of antimicrobial susceptibility of
• 03573026618742: ETEST® is a manual, quantitative technique for determination of antimicrobial susceptibility of
• 03573026618728: ETEST® is a manual, quantitative technique for determination of antimicrobial susceptibility of
• 03573026618704: ETEST® is a manual, quantitative technique for determination of antimicrobial susceptibility of
• 03573026618681: ETEST® is a manual, quantitative technique for determination of antimicrobial susceptibility of
• 03573026618667: ETEST® is a manual, quantitative technique for determination of antimicrobial susceptibility of
• 03573026618650: ETEST® is a manual, quantitative technique for determination of antimicrobial susceptibility of
• 03573026618636: ETEST® is a manual, quantitative technique for determination of antimicrobial susceptibility of
• 03573026618612: ETEST® is a manual, quantitative technique for determination of antimicrobial susceptibility of
• 03573026618599: ETEST® is a manual, quantitative technique for determination of antimicrobial susceptibility of
• 03573026618575: ETEST® is a manual, quantitative technique for determination of antimicrobial susceptibility of
• 03573026618551: ETEST® is a manual, quantitative technique for determination of antimicrobial susceptibility of
• 03573026618216: ETEST® is a manual, quantitative technique for determination of antimicrobial susceptibility of
• 03573026619701: ETEST® is a manual, quantitative technique for determination of antimicrobial susceptibility of
• 03573026618292: ETEST® is a manual, quantitative technique for determination of antimicrobial susceptibility of
• 03573026619671: ETEST® is a manual, quantitative technique for determination of antimicrobial susceptibility of
• 03573026619657: ETEST® is a manual, quantitative technique for determination of antimicrobial susceptibility of
• 03573026619633: ETEST® is a manual, quantitative technique for determination of antimicrobial susceptibility of
• 03573026619619: ETEST® is a manual, quantitative technique for determination of antimicrobial susceptibility of
• 03573026619596: ETEST® is a manual, quantitative technique for determination of antimicrobial susceptibility of
• 03573026619565: ETEST® is a manual, quantitative technique for determination of antimicrobial susceptibility of
• 03573026618803: ETEST® is a manual, quantitative technique for determination of antimicrobial susceptibility of
• 03573026623593: ETEST® is a manual, quantitative technique for determination of antimicrobial susceptibility of
• 03573026623586: ETEST® is a manual, quantitative technique for determination of antimicrobial susceptibility of
• 03573026623548: ETEST® is a manual, quantitative technique for determination of antimicrobial susceptibility of
• 03573026623524: ETEST® is a manual, quantitative technique for determination of antimicrobial susceptibility of
• 03573026619855: ETEST® is a manual, quantitative technique for determination of antimicrobial susceptibility of
• 03573026619749: ETEST® is a manual, quantitative technique for determination of antimicrobial susceptibility of
• 03573026623562: ETEST® is a manual, quantitative technique for determination of antimicrobial susceptibility of
• 03573026619831: ETEST® is a manual, quantitative technique for determination of antimicrobial susceptibility of
• 03573026619800: ETEST® is a manual, quantitative technique for determination of antimicrobial susceptibility of