LIAISON® Biotrin Control Parvovirus B19 IgG Plus

GUDID 08056771104036

Italy manufactured kit.

DIASORIN SPA

Parvovirus B19 immunoglobulin G (IgG) antibody IVD, control

• Primary Device ID: 08056771104036
• NIH Device Record Key: 43f06767-2d03-49e4-82e0-0838987fa52e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LIAISON® Biotrin Control Parvovirus B19 IgG Plus
• Version Model Number: 311551
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	08056771104036 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P220034

FDA Product Code

• MYL: Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg

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: 2024-04-16
• Device Publish Date: 2024-04-08

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: 2024-04-16Italy 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