Alere™ BinaxNOW® Legionella Control Swab Kit

Basic Information

• Brand Name: Alere™ BinaxNOW® Legionella Control Swab Kit
• Primary DI: 10811877010491
• Version / Model: 852-010
• Company Name: Alere Scarborough, Inc.
• Labeler DUNS: 154148498
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-01
• Public Version: 3
• Public Version Date: 2023-09-12
• Public Version Status: Update
• Public Device Record Key: 85a9e40e-c6b2-4c7b-8430-8a761a01298f
• Distribution End Date: 2021-05-28

Device Description

Control swabs intended for use only with Legionella product manufactured by Alere Scarborough, Inc.

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
51058	Legionella pneumophila antigen IVD, control	A material which is used to verify the performance of an assay intended to be 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	10811877010491	GS1

Premarket Submissions

Submission Number	Supplement Number
K070522	000