BinaxNOW® Malaria

Basic Information

• Brand Name: BinaxNOW® Malaria
• Primary DI: 10811877010378
• Version / Model: 665-025
• Company Name: Alere Scarborough, Inc.
• Labeler DUNS: 154148498
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-03
• Public Version: 5
• Public Version Date: 2023-09-12
• Public Version Status: Update
• Public Device Record Key: 5f48d5a5-fd16-4e04-aadf-7af29a3b48ff

Device Description

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OAX	Plasmodium Spp. Detection Reagents	Microbiology	866.3402	2

GMDN Terms

Code	Name	Definition	Implantable	Status
52311	Multiple Plasmodium species antigen IVD, kit, rapid ICT, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from multiple species of Plasmodium, the malaria parasites (e.g., P. falciparum, P. vivax, P. ovale, P. knowlesi, P. malariae), in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10811877010378	GS1

Premarket Submissions

Submission Number	Supplement Number
DEN070006	000