Legionella micdadei DFA Reagent

Basic Information

• Brand Name: Legionella micdadei DFA Reagent
• Primary DI: 10628429001728
• Version / Model: PL.210
• Catalog Number: PL.210
• Company Name: PRO-LAB, INCORPORATED
• Labeler DUNS: 960418395
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-25
• Public Version: 1
• Public Version Date: 2023-01-02
• Public Version Status: New
• Public Device Record Key: df5db125-111a-4e2f-89f2-6f4249235ae9

Device Description

L. pneumophila serogroup 2

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LHL	Reagents, Antibody, Legionella, Direct & Indirect Fluorescent	Microbiology	866.3300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62353	Multiple Legionella species immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to multiple species of Legionella bacteria in a clinical specimen, using a fluorescent immunoassay method. Legionella species intended to be detected may include Legionella pneumophila, L. longbeachae, L. jordanis, L. bozemanii, L. gormanii, L. micdadei, and L. dumoffii which are associated with pneumonia-like respiratory infection and Legionnaires' disease.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10628429001728	GS1