Binax® Legionella EIA Wash Buffer Accessory Kit

GUDID 10811877010767

Wash Buffer intended for use only with Binax™ Legionella Urinary Antigen Enzyme Immunoassay kit.

Alere Scarborough, Inc.

Legionella pneumophila antigen IVD, reagent Legionella pneumophila antigen IVD, reagent Legionella pneumophila antigen IVD, reagent Legionella pneumophila antigen IVD, reagent Legionella pneumophila antigen IVD, reagent Legionella pneumophila antigen IVD, reagent Legionella pneumophila antigen IVD, reagent Legionella pneumophila antigen IVD, reagent Legionella pneumophila antigen IVD, reagent Legionella pneumophila antigen IVD, reagent Legionella pneumophila antigen IVD, reagent Legionella pneumophila antigen IVD, reagent Legionella pneumophila antigen IVD, reagent Legionella pneumophila antigen IVD, reagent Legionella pneumophila antigen IVD, reagent Legionella pneumophila antigen IVD, reagent Legionella pneumophila antigen IVD, reagent

• Primary Device ID: 10811877010767
• NIH Device Record Key: 7acf0310-b87e-4c50-bcca-cef2352beeaf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Binax® Legionella EIA Wash Buffer Accessory Kit
• Version Model Number: 851-100
• 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	10811877010767 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K934965

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: 2023-09-12
• Device Publish Date: 2016-09-03

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