BinaxNOW RSV

GUDID 10811877011184

A rapid test for the qualitative detection of respiratory syncytial virus (RSV) in nasal wash and nasopharyngeal swab specimens.

Alere Scarborough, Inc.

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• Primary Device ID: 10811877011184
• NIH Device Record Key: 31af3448-a6df-42c2-86d7-a0bfe84ef391
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BinaxNOW RSV
• Version Model Number: 430-100
• 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: 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	10811877011184 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032166

FDA Product Code

• GQG: Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus

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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