dIFine ANCA Classifier

GUDID 08059304340239

VISIA LAB SRL

Laboratory instrument/analyser application software IVD

• Primary Device ID: 08059304340239
• NIH Device Record Key: 89c79d3d-4e69-4cb8-8a96-39b244bd4bcc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: dIFine ANCA Classifier
• Version Model Number: dIFine ANCA Classifier
• 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	08059304340239 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243776

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: 2025-07-07
• Device Publish Date: 2025-06-27

Devices Manufactured by VISIA LAB SRL

• 08059304340147 - dIFine P15: 2025-07-07
• 08059304340239 - dIFine ANCA Classifier: 2025-07-07
• 08059304340239 - dIFine ANCA Classifier: 2025-07-07
• 08059304340215 - dIFine ANA HEp-2 Classifier: 2024-11-18
• 08059304340222 - dIFine DNA Classifier: 2024-11-18
• 08059304340123 - SP30: 2023-06-13
• 08059304340109 - Zeus dIFine: 2022-09-15