A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens.

A rapid test for the qualitative detection of COVID
BinaxNOW COVID-19 Antigen Self Test - 195-160

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.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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 Id: 00811877011408

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