QuickVue At
QuickVue - 20402
Device Description
A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2), the causative agent of coronavirus disease (COVID-19), in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test intended to be used for self-testing by a layperson in the home or similar environment.
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: QKP
Device Name: Coronavirus Antigen Detection Test System.
Device Class: N
Physical State: In vitro diagnostic device
Definition: The qualitative detection of coronavirus viral antigens directly from clinical specimens.
Submission Type ID: 8
Review Panel: MI
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: Antigen detection
Life Sustain Support Flag: N
Unclassified Reason: 11
Implant Flag: N
Target Area: Clinical specimens.
Regulation Number: N/A
Third Party Flag: N
Medical Specialty: N/A
Device IdentifiersDevice Id: 30014613339724
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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