LIAISON® QuantiFERON® Software

GUDID 08056771103572

DIASORIN SPA

Laboratory instrument/analyser application software IVD

• Primary Device ID: 08056771103572
• NIH Device Record Key: 0ddb3a15-5d67-47b6-a8d7-7cc22ffbdb63
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LIAISON® QuantiFERON® Software
• Version Model Number: Q0001
• Company DUNS: 630822989
• Company Name: DIASORIN SPA
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• 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	08056771103572 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P180047

FDA Product Code

• NCD: Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

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: 2019-12-17
• Device Publish Date: 2019-12-09

Devices Manufactured by DIASORIN SPA

• 08056771104029 - LIAISON® Biotrin Parvovirus B19 IgG Plus: 2024-04-16 Italy manufactured kit.
• 08056771104036 - LIAISON® Biotrin Control Parvovirus B19 IgG Plus: 2024-04-16 Italy manufactured kit.
• 08056771104166 - LIAISON® VZV IgG HT: 2024-03-25
• 08056771104173 - LIAISON® Control VZV IgG HT: 2024-03-25
• 08056771104098 - LIAISON QUANTIferon TB Gold Plus: 2023-12-22 Italy manufactured kit.
• 08056771104081 - LIAISON QUANTIferon TB Gold Plus: 2023-09-18 Italy manufactured kit.
• 08056771603300 - LIAISON QUANTIferon TB Gold Plus: 2023-07-31
• 08056771200103 - LIAISON® ENDOCRINOLOGY DILUENT: 2023-06-02