Binax® Legionella Urinary Antigen EIA

Basic Information

• Brand Name: Binax® Legionella Urinary Antigen EIA
• Primary DI: 10811877010460
• Version / Model: 851-000
• 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: 3
• Public Version Date: 2023-09-12
• Public Version Status: Update
• Public Device Record Key: 6d88293b-e714-46a7-a7ec-bc7de30bc3fd

Device Description

For the qualitative detection of Legionella pneumophila serogroup 1 antigen in human urine.

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
MJH	Legionella, Spp., Elisa	Microbiology	866.3300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
51056	Legionella pneumophila antigen IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from one or multiple serogroups of Legionella pneumophila in a clinical specimen, using an enzyme immunoassay (EIA) method. The assay is designed to detect infection with Legionella pneumophila, the bacteria associated with Legionnaires' disease.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10811877010460	GS1

Premarket Submissions

Submission Number	Supplement Number
K934965	000