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
