Binax® Legionella EIA Wash Buffer Accessory Kit

Basic Information

• Brand Name: Binax® Legionella EIA Wash Buffer Accessory Kit
• Primary DI: 10811877010767
• Version / Model: 851-100
• 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: 7acf0310-b87e-4c50-bcca-cef2352beeaf

Device Description

Wash Buffer intended for use only with Binax™ Legionella Urinary Antigen Enzyme Immunoassay kit.

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: No
• 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
51059	Legionella pneumophila antigen IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of antigens from one or multiple serogroups of Legionella pneumophila bacteria in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10811877010767	GS1

Premarket Submissions

Submission Number	Supplement Number
K934965	000