Legionella IFA

Legionella IFA - IF0950

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total antibodies to one or multiple serogroups of Legionella pneumophila in a clinical specimen, using a fluorescent immunoassay method. The assay is designed to detect infection with Legionella pneumophila, the bacteria associated with Legionnaires' disease.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: LHL

Device Name: Reagents, Antibody, Legionella, Direct & Indirect Fluorescent

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 Id: 20816101020045

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