BinaxNOW® Malaria

GUDID 10811877010378

For the qualitative detection of Plasmodium falciparum (P.f.) and pan-malarial antigens.

Alere Scarborough, Inc.

Multiple Plasmodium species antigen IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 10811877010378
• NIH Device Record Key: 5f48d5a5-fd16-4e04-aadf-7af29a3b48ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BinaxNOW® Malaria
• Version Model Number: 665-025
• 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	10811877010378 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN070006

FDA Product Code

• OAX: Plasmodium Spp. Detection Reagents

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

On-Brand Devices [BinaxNOW® Malaria]

• 10811877010378: For the qualitative detection of Plasmodium falciparum (P.f.) and pan-malarial antigens.
• 10811877010361: For the qualitative detection of Plasmodium falciparum (P.f.) and pan-malarial antigens.