BACT/ALERT

GUDID 03573026629649

R3.1 SW/FW for BACT/ALERT VIRTUO

BIOMERIEUX , INC.

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