LIAISON MeMed BV

GUDID 08056771602969

The DiaSorin LIAISON MeMed BV is a semi-quantitative assay that uses chemiluminescent immunoassay (CLIA) technology to measure three non-microbial (host) proteins (TRAIL, IP-10, and CRP) in adult and pediatric serum samples.

Diasorin Inc.

Multiple cell-mediated host immune response marker IVD, chemiluminescent immunoassay, rapid

• Primary Device ID: 08056771602969
• NIH Device Record Key: a54ff23f-dcea-48f3-bba4-b75a28be2c52
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LIAISON MeMed BV
• Version Model Number: 318470
• Company DUNS: 033429783
• Company Name: Diasorin 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: true
• 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	08056771602969 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213936

FDA Product Code

• QPS: Immunoassay For Host Biomarkers Of Infection

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: 2022-08-18
• Device Publish Date: 2022-08-10

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• 08056771600903 - CT-2 Immunoscreen Fluoro-Kit™: 2026-02-09
• 08056771600910 - RS Fluoro-Kit™: 2026-02-09