BinaxNOW COVID-19 Ag Positive Control Swab Pack

Basic Information

• Brand Name: BinaxNOW COVID-19 Ag Positive Control Swab Pack
• Primary DI: 10811877011306
• Version / Model: 195-080
• Company Name: Alere Scarborough, Inc.
• Labeler DUNS: 154148498
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-01
• Public Version: 2
• Public Version Date: 2023-09-12
• Public Version Status: Update
• Public Device Record Key: 9bef320c-753e-47d0-80d7-be1c972bedd7

Device Description

Control swabs intended for use only with BinaxNOW COVID-19 Ag product manufactured by Abbott Diagnostics Scarborough, Inc.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QKP	Coronavirus Antigen Detection Test System.	Unknown		N

GMDN Terms

Code	Name	Definition	Implantable	Status
64922	SARS-CoV-2 antigen IVD, control	A material which is used to verify the performance of an assay intended to be 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10811877011306	GS1