Legionella pneumophila Screening (Mix 1/2/3/4) IFA (IgAGM)

Basic Information

• Brand Name: Legionella pneumophila Screening (Mix 1/2/3/4) IFA (IgAGM)
• Primary DI: 04049016053156
• Version / Model: FI 2150-1005-3 P
• Company Name: EUROIMMUN Medizinische Labordiagnostika AG
• Labeler DUNS: 322209263
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 3
• Public Version Date: 2018-09-14
• Public Version Status: Update
• Public Device Record Key: baef80b0-7845-4719-9e83-2832e6fff9c0
• Distribution End Date: 2018-09-11

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
51050	Legionella pneumophila total 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 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	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04049016053156	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius