The DiaSorin LIAISON MeMed BV is a semi
LIAISON MeMed BV - 318470
Device Description
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.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
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 IdentifiersDevice 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
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