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.

The DiaSorin LIAISON MeMed BV is a semi
LIAISON MeMed BV - 318470

A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of multiple cell-mediated (i.e., non-immunoglobulin) host immune response markers of bacterial and/or viral infection in a clinical specimen within a short period, relative to standard laboratory testing procedures, using a chemiluminescent immunoassay method. It is typically used to differentiate bacterial from viral infection, and/or to predict patient outcomes by grading disease severity. It is not intended to be used for self-testing.

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Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: QPS

Device Name: Immunoassay For Host Biomarkers Of Infection

Device Class: 2

Physical State: In vitro diagnostic device

Definition: A semi-quantitative immunoassay that quantifies the relative levels of host response proteins isolated from serum or similar specimens.

Submission Type ID: 1

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Chemiluminescent immunoassay

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Human serum or similar samples

Regulation Number: 866.3215

Third Party Flag: N

Medical Specialty: MI

Device Id: 08056771602969

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A