A rapid test for the qualitative detection of COVID
BinaxNOW COVID-19 Antigen Self Test - 195-170
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: QYT
Device Name: Over-The-Counter Covid-19 Antigen Test
Device Class: 2
Physical State: Solid phase test device/dip-stick
Definition: For the rapid, qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen in individuals 2 years and older.
Submission Type ID: 1
Review Panel: MI
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: Lateral flow Immunochromatographic Assay
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: Anterior Nasal Swabs
Regulation Number: 866.3984
Third Party Flag: N
Medical Specialty: MI
Device Identifiers
Device Id: 00811877011118
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
