BinaxNOW Strep A Card

GUDID 10811877010927

A rapid test for the qualitative detection of Streptococcus pyogenes Group A antigen from throat swab specimens.

Alere Scarborough, Inc.

Beta-haemolytic Group A Streptococcus antigen IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 10811877010927
• NIH Device Record Key: 3fb39248-a19c-43b1-8216-492b9d2630a2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BinaxNOW Strep A Card
• Version Model Number: 735-025
• 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	10811877010927 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K960712

FDA Product Code

• GTZ: Antisera, All Groups, Streptococcus Spp.

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: 2020-09-24
• Device Publish Date: 2020-09-16

On-Brand Devices [BinaxNOW Strep A Card]

• 10811877010927: A rapid test for the qualitative detection of Streptococcus pyogenes Group A antigen from throat
• 10811877010453: A rapid test for the qualitative detection of Streptococcus pyogenes Group A antigen from throat