BACT/ALERT

GUDID 03573026629649

R3.1 SW/FW for BACT/ALERT VIRTUO

BIOMERIEUX , INC.

Blood culture analyser IVD Blood culture analyser IVD Blood culture analyser IVD Blood culture analyser IVD Blood culture analyser IVD Blood culture analyser IVD Blood culture analyser IVD Blood culture analyser IVD Blood culture analyser IVD Blood culture analyser IVD Blood culture analyser IVD Blood culture analyser IVD Blood culture analyser IVD Blood culture analyser IVD Blood culture analyser IVD Blood culture analyser IVD Blood culture analyser IVD

• Primary Device ID: 03573026629649
• NIH Device Record Key: 0dcd50dd-a3fd-4689-aca3-535ce1c9ebfb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BACT/ALERT
• Version Model Number: R3.1
• Company DUNS: 086785110
• Company Name: BIOMERIEUX , INC.
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	03573026629649 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161816

FDA Product Code

• MDB: System, blood culturing

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: 2023-09-25
• Device Publish Date: 2023-09-15

On-Brand Devices [BACT/ALERT]

• 03573026428853: Designed for recovery and detection of mycobacteria from sterile body specimens other than blood
• 03573026629649: R3.1 SW/FW for BACT/ALERT VIRTUO