BinaxNOW® Malaria Positive Control Kit

GUDID 10811877010712

The BinaxNOW® Malaria Positive Control.

Alere Scarborough, Inc.

Multiple Plasmodium species antigen IVD, control Multiple Plasmodium species antigen IVD, control Multiple Plasmodium species antigen IVD, control Multiple Plasmodium species antigen IVD, control Multiple Plasmodium species antigen IVD, control Multiple Plasmodium species antigen IVD, control Multiple Plasmodium species antigen IVD, control Multiple Plasmodium species antigen IVD, control Multiple Plasmodium species antigen IVD, control Multiple Plasmodium species antigen IVD, control Multiple Plasmodium species antigen IVD, control Multiple Plasmodium species antigen IVD, control Multiple Plasmodium species antigen IVD, control Multiple Plasmodium species antigen IVD, control Multiple Plasmodium species antigen IVD, control Multiple Plasmodium species antigen IVD, control Multiple Plasmodium species antigen IVD, control 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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