FDA.report

Healgen

Primary DI
00850076346027
Brand
Healgen
Company
HEALGEN LIFE SCIENCE, LLC
Model
FBFEN-102G
Device description
Healgen AccuFluor Fentanyl Fluorescence Immunoassay (FIA) Test Kit - Qualitative is a fluorescence immunoassay intended for the qualitative detection of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. The assay is intended for use with Healgen® Immunofluorescence analyzer OG-H180. This in vitro diagnostic device is for prescription use only.
Published
2026-02-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
DJGEnzyme Immunoassay, Opiates

Product Code Classifications

CodeDeviceSpecialtyClass
DJGEnzyme Immunoassay, OpiatesClinical Toxicology2

Premarket Submissions

SubmissionSupplement
K251972000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K251972000Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180)Healgen Scientific,, LLC2025-08-15DJG

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10850076346024PackageGS125In Commercial Distribution
20850076346021PackageGS172In Commercial Distribution
00850076346027PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1085007634602410850076346024
2085007634602120850076346021
00850076346027008500763460278500763460270850076346027

GMDN Terms

TermDefinition
Fentanyl IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of fentanyl in a clinical specimen.

Sterilization Methods

Method

Contacts

PhoneEmail
713-7338088bryan.fang@healgen.com

Regulatory Flags

DUNS number
098183434
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
10850076346017HealgenOG-H1802026-02-06

Other Devices Sharing Product Codes

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10810173655740HealgenHealgen Scientific Limited Liability CompanyDJG2026-01-30
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10810173652169HealgenHealgen Scientific Limited Liability CompanyDJG2025-12-19
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