CMV IgG Atellica IM
Atellica IM CMV IgG Quality Control - 11202209
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 G (IgG) antibodies to cytomegalovirus (CMV) in a clinical specimen.
Environmental Conditions
- Store Upright, Do not Freeze, Resuspend
- 8.00
- 2.00
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: 00630414246482
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
Device Id: 00630414283920
Device Type: Unit of Use
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