LIAISON® XL Zika Capture IgM II Control Set - 317151
Device Description
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of immunoglobulin M (IgM) antibodies to Zika virus in a clinical specimen.
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 IdentifiersDevice Id: 08056771602648
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