Reagent Accessory Pack intended for use only with BinaxNOW™ COVID
BinaxNOW COVID-19 Reagent Accessory Kit - 195-090
Device Description
A substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of antigens from severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2), the causative agent of COVID-19, in a clinical specimen.
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: 00811877011576
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