PREVI® COLOR DUAL SAMPLE CHAMBERS SLOW (TAN)

GUDID 03573026615185

The chamber features a sample loading system that places a spot on the microscope slide.

BIOMERIEUX SA

Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD

• Primary Device ID: 03573026615185
• NIH Device Record Key: d5a703ed-2f61-4fe3-b962-e00961986c51
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PREVI® COLOR DUAL SAMPLE CHAMBERS SLOW (TAN)
• Version Model Number: PREVI® COLOR DUAL SAMPLE CHAMBERS SLOW (TAN)
• Company DUNS: 276816717
• Company Name: BIOMERIEUX SA
• Device Count: 48
• DM Exempt: false
• Pre-market Exempt: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03573026227739 [Primary]
GS1	03573026615185 [Unit of Use]

FDA Product Code

• KPA: Slide stainer, automated

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: 2020-08-24
• Device Publish Date: 2020-08-14

Devices Manufactured by BIOMERIEUX SA

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• 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