Healgen

Basic Information

• Brand Name: Healgen
• Primary DI: 00850076346010
• Version / Model: OG-H180
• Company Name: HEALGEN LIFE SCIENCE, LLC
• Labeler DUNS: 098183434
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-02-06
• Public Version: 1
• Public Version Date: 2026-02-16
• Public Version Status: New
• Public Device Record Key: 43ac51a3-b7f8-42e1-844f-a8c113da4845

Device Description

The Healgen Immunofluorescence analyzer OG-H180 is a portable fluorescence instrument for in vitro diagnostic use only. It is designed to perform in vitro diagnostic tests on clinical specimens including drug urine test.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: No
• Has Serial Number: Yes
• 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
KHO	Fluorometer, For Clinical Use	Clinical Chemistry	862.2560	1

GMDN Terms

Code	Name	Definition	Implantable	Status
48014	Fluorescent immunoassay analyser IVD, point-of-care	A portable, electrically-powered instrument typically used to scan an immunoassay reagent vehicle (e.g., test strip, cassette, or card) after exposure to a clinical specimen, to provide a quantitative, semi-quantitative, and/or qualitative in vitro determination of chemical substances and/or biological markers in a clinical specimen. The instrument detects fluorescent markers that result from the immunological reaction between the reagents and the specimen. It is mostly used for rapid in vitro diagnostic measurements at the point-of-care and in the laboratory.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10850076346017	GS1	Inner pack	1	In Commercial Distribution
Primary	00850076346010	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K251972	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 30 Degrees Celsius