Anti-Lactoferrin ELISA

Basic Information

• Brand Name: Anti-Lactoferrin ELISA
• Primary DI: 00840239036025
• Version / Model: EIA-3602
• Catalog Number: EIA-3602
• Company Name: DRG International Inc
• Labeler DUNS: 075150847
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-25
• Public Version: 1
• Public Version Date: 2023-09-04
• Public Version Status: New
• Public Device Record Key: 84ef371a-b073-4e8f-b1e3-b4c9e3debfe4

Device Description

Anti-Lactoferrin ELISA is a test system for the quantitative measurement of IgG class autoantibodies against Lactoferrin in human serum or plasma.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: Yes
• 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
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	870.2910	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65652	Multiple-type respiratory pathogen immunoglobulin M (IgM) 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 M (IgM) antibodies to multiple types of respiratory pathogens (e.g., viruses and bacteria) in a clinical specimen, using a fluorescent immunoassay method. Organisms intended to be detected may include Legionella pneumophila, Mycoplasma pneumoniae, Coxiella burnetiid, Chlamydophila pneumoniae, respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, and/or adenovirus.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840239036025	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

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