CHROMID® MRSA agar

GUDID 03573026313111

Chromogenic medium for the screening and qualitative detection of methicillin-resistant Staphylococcus aureus (MRSA)

BIOMERIEUX SA

Differential/selective agar culture medium IVD

• Primary Device ID: 03573026313111
• NIH Device Record Key: 322f21dc-3423-4294-bf9d-82bf63370b8c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CHROMID® MRSA agar
• Version Model Number: chromID® MRSA agar
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03573026313111 [Package]; Contains: 03573026552114; Package: [2 Units]; In Commercial Distribution
GS1	03573026552114 [Primary]
GS1	03573026552121 [Unit of Use]

FDA Product Code

• JSO: Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar

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: 2020-01-14
• Device Publish Date: 2016-09-23

Devices Manufactured by BIOMERIEUX SA

• 03573026256685 - ETEST® Gentamicin (GM): 2024-04-15 Etest is a quantitative technique for determining susceptibility of clinically significant bacteria. It provides a gradient of 1
• 03573026376604 - ETEST® Amoxicillin (AC): 2024-04-15 Etest is a quantitative technique for determining susceptibility of clinically significant bacteria. It provides a gradient of 1
• 03573026377731 - ETEST® Flucytosine (FC): 2024-04-15 Etest is a quantitative technique for determining susceptibility of antifungal. It provides a gradient of 15 doubling dilutions
• 03573026560690 - ETEST® Meropenem/Vaborbactam (MEV): 2024-04-15 ETEST® is a manual, quantitative technique for determination of antimicrobial susceptibility of non-fastidious Gram-negative an
• 03573026475352 - ETEST® Telavancin (TLA): 2024-04-12 Etest is a quantitative technique for determining susceptibility of clinically significant bacteria. It provides a gradient of 1
• 03573026252526 - ETEST® Cefepime (PM): 2024-04-08 Etest is a quantitative technique for determining susceptibility of clinically significant bacteria. It provides a gradient of 1
• 03573026253219 - Etest® TIC/CLAV-CON2: 2024-04-08 Etest is a quantitative technique for determining susceptibility of clinically significant bacteria. It provides a gradient of 1
• 03573026617851 - VITEK®MS: 2024-03-18 VITEK MS ready to use reagent for calibration and fine tuning of the VITEK MS instrument