GeroaDX

Basic Information

• Brand Name: GeroaDX
• Primary DI: 08437029987012
• Version / Model: 1
• Company Name: GEROA DIAGNOSTICS SOCIEDAD LIMITADA.
• Labeler DUNS: 466966807
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-12-10
• Public Version: 1
• Public Version Date: 2025-12-18
• Public Version Status: New
• Public Device Record Key: 37df111a-73c0-44da-8ca9-4a6b4ed76f12

Device Description

ELISA Kit for Human Lactoferrin For In Vitro Diagnostic Use

Device Characteristics

• Single Use: No
• 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: Yes

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DEG	Lactoferrin, Antigen, Antiserum, Control	Immunology	866.5570	1

GMDN Terms

Code	Name	Definition	Implantable	Status
53909	Lactoferrin IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of lactoferrin in a clinical specimen, using an enzyme immunoassay (EIA) method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08437029987012	GS1

Storage Conditions

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