Alere™ BinaxNOW® Legionella Urinary Antigen Card

GUDID 10811877010477

The Alere BinaxNOW® Legionella Urinary Antigen Card is an in vitro rapid immunochromatographic assay for the qualitative detection of Legionella pneumophila serogroup 1 antigen in urine specimens from patients with symptoms of pneumonia.

Alere Scarborough, Inc.

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• Primary Device ID: 10811877010477
• NIH Device Record Key: 2095aca7-d0ce-4f13-b4a6-9297a188c877
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alere™ BinaxNOW® Legionella Urinary Antigen Card
• Version Model Number: 852-000
• 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: 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	10811877010477 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070522

FDA Product Code

• MJH: Legionella, Spp., Elisa

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: 2016-09-01

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