The Alere BinaxNOW® Legionella Urinary Antigen Card is an in vitro rapid immunochromatographic assay for the qualitative detection of Legionella pneumophila serogroup 1 antigen in urine specimens from patients with symptoms of pneumonia.
Alere™ BinaxNOW® Legionella Urinary Antigen Card - 852-000
Device Description
A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from one or multiple serogroups of Legionella pneumophila 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 to detect infection with Legionella pneumophila, the bacteria associated with Legionnaires' disease. It is not intended to be used for self-testing.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: MJH
Device Name: Legionella, Spp., Elisa
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: MI
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 866.3300
Third Party Flag: N
Medical Specialty: MI
Device IdentifiersDevice Id: 10811877010477
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A