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


Product Overview

Wash Buffer intended for use only with Binax™ Legionella Urinary Antigen Enzyme Immunoassay kit.
Binax® Legionella EIA Wash Buffer Accessory Kit - 851-100


Device Description

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.


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 Identifiers

Device Id: 10811877010767

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


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