BinaxNOW™ Legionella Control Swab Pack

GUDID 10811877011054

Control Swabs to be used with the BinaxNOW™ Legionella Urinary Antigen Card.

Alere Scarborough, Inc.

Legionella pneumophila antigen IVD, control Legionella pneumophila antigen IVD, control Legionella pneumophila antigen IVD, control Legionella pneumophila antigen IVD, control Legionella pneumophila antigen IVD, control Legionella pneumophila antigen IVD, control Legionella pneumophila antigen IVD, control Legionella pneumophila antigen IVD, control Legionella pneumophila antigen IVD, control Legionella pneumophila antigen IVD, control Legionella pneumophila antigen IVD, control Legionella pneumophila antigen IVD, control Legionella pneumophila antigen IVD, control Legionella pneumophila antigen IVD, control Legionella pneumophila antigen IVD, control Legionella pneumophila antigen IVD, control Legionella pneumophila antigen IVD, control Legionella pneumophila antigen IVD, control

• Primary Device ID: 10811877011054
• NIH Device Record Key: 27aeae37-cd5b-44d7-884b-9bc5f8ea8d1e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BinaxNOW™ Legionella Control Swab Pack
• Version Model Number: 852-010
• 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: 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	10811877011054 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-07-23
• Device Publish Date: 2019-07-15

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