M45d Test Reagent Species

Basic Information

• Brand Name: M45d Test Reagent Species
• Primary DI: 05060446290248
• Version / Model: M45d
• Company Name: MICROGEN BIOPRODUCTS LIMITED
• Labeler DUNS: 231128802
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-06-30
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: ec833c9d-f10e-4c4e-9d61-eb3de8f42e28

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• 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
51055	Legionella pneumophila antigen IVD, kit, agglutination	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from one or multiple serogroups of Legionella pneumophila in a clinical specimen, using an agglutination 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	05060446290248	GS1