Alere Reader BinaxNOW Tray Pack

GUDID 10811877011016

A tray insert to be used with the Alere Reader to ensure correct placement of the immunoassay reagent vehicle (e.g., test strip, cassette, or card).

Alere Scarborough, Inc.

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• Primary Device ID: 10811877011016
• NIH Device Record Key: 874dec3b-3ed6-4044-a768-5a5b5e7b81f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alere Reader BinaxNOW Tray Pack
• Version Model Number: LFR-004
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	10811877011016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162642

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2022-06-10
• Device Publish Date: 2017-12-28

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