Zeus dIFine

GUDID 08059304340109

VISIA LAB SRL

Scanning laser optical microscope Scanning laser optical microscope Scanning laser optical microscope Scanning laser optical microscope Scanning laser optical microscope Scanning laser optical microscope Scanning laser optical microscope Scanning laser optical microscope Scanning laser optical microscope Scanning laser optical microscope Scanning laser optical microscope Scanning laser optical microscope Scanning laser optical microscope Scanning laser optical microscope Scanning laser optical microscope Scanning laser optical microscope Scanning laser optical microscope Scanning laser optical microscope Scanning laser optical microscope Scanning laser optical microscope Scanning laser optical microscope Scanning laser optical microscope Scanning laser optical microscope Scanning laser optical microscope Scanning laser optical microscope Scanning laser optical microscope Scanning laser optical microscope Scanning laser optical microscope Scanning laser optical microscope Scanning laser optical microscope Scanning laser optical microscope Scanning laser optical microscope Scanning laser optical microscope

• Primary Device ID: 08059304340109
• NIH Device Record Key: 22378efa-871c-4860-92a7-3c2a7a7382af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zeus dIFine
• Version Model Number: Zeus dIFine
• Company DUNS: 441255829
• Company Name: VISIA LAB SRL
• 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: false
• Serial Number: true
• Manufacturing Date: true
• 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	08059304340109 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201956

FDA Product Code

• PIV: Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use

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: 2022-09-15
• Device Publish Date: 2022-09-07

Devices Manufactured by VISIA LAB SRL

• 08059304340123 - SP30: 2023-06-13
• 08059304340109 - Zeus dIFine: 2022-09-15
• 08059304340109 - Zeus dIFine: 2022-09-15