BinaxNOW® Malaria Positive Control Kit

GUDID 10811877010712

The BinaxNOW® Malaria Positive Control.

Alere Scarborough, Inc.

Multiple Plasmodium species antigen IVD, control

• Primary Device ID: 10811877010712
• NIH Device Record Key: f02a5718-363d-4c18-b5d3-6022eb6b9f55
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BinaxNOW® Malaria Positive Control Kit
• Version Model Number: 665-010
• 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	10811877010712 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083744

FDA Product Code

• MJZ: Kit, Direct Antigen, Positive Control

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: 2019-10-07
• Device Publish Date: 2016-09-03

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