DV/DM COV2G/CV2G POS/NEG CTRL
DV/DM COV2G/CV2G POS/NEG CTRL - 11417773
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 severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2), the causative agent of COVID-19, in a clinical specimen.
Environmental Conditions
- -15.00
- -25.00
- Store Upright
- -15.00
- -25.00
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 Identifiers
Device Id: 00630414298405
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
Device Id: 00630414607054
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
