BinaxNOW Strep A Control Swab Pack

GUDID 10811877010446

Control swabs intended for use only with Strep A product.

Alere Scarborough, Inc.

Beta-haemolytic Group A Streptococcus antigen IVD, control

• Primary Device ID: 10811877010446
• NIH Device Record Key: 4d75a8b8-81c3-47d9-9f2c-ad10e6ee49c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BinaxNOW Strep A Control Swab Pack
• Version Model Number: 730-010
• 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	10811877010446 [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

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