BinaxNOW COVID-19 Ag Card Home Test

GUDID 10811877011337

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

Alere Scarborough, Inc.

SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 10811877011337
• NIH Device Record Key: a022e689-8ce4-4621-b369-66479a95ea9e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BinaxNOW COVID-19 Ag Card Home Test
• Version Model Number: 195-200
• Company DUNS: 154148498
• Company Name: Alere Scarborough, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10811877011337 [Primary]

FDA Product Code

• QKP: Coronavirus Antigen Detection Test System.

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-01-05
• Device Publish Date: 2020-12-28

On-Brand Devices [BinaxNOW COVID-19 Ag Card Home Test]

• 00811877011330: A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens
• 10811877011337: A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens