The DiaSorin LIAISON MeMed BV Control Set is intended for use as assayed quality control samples to monitor the performance of the DiaSorin LIAISON® MeMed BV assay.


Product Overview

The DiaSorin LIAISON MeMed BV Control Set is intended for use as assayed quality control samples to monitor the performance of the DiaSorin LIAISON® MeMed BV assay.
LIAISON MeMed BV Control Set - 318471


Device Description

A material which is used to verify the performance of an assay 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. It is typically used to aid in the differentiation of bacterial and viral infection, and/or to predict patient outcomes by grading disease severity.


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: QCH

Device Name: Assayed Quality Control Material For Clinical Microbiology Assays

Device Class: 2

Physical State: Liquid or solid

Definition: Serologic controls for microbiology assays

Submission Type ID: 1

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: For use with serologic microbiology assays

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Not applicable

Regulation Number: 866.3920

Third Party Flag: N

Medical Specialty: MI


Device Identifiers

Device Id: 08056771602976

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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