FDA UDI
In Commercial Distribution
🇺🇸 United States
Healgen
DI: 00850076346027
·
Model: FBFEN-102G
·
HEALGEN LIFE SCIENCE, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Healgen
- Primary DI
- 00850076346027
- Version / Model
- FBFEN-102G
- 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
- c6b1d138-151a-4c61-ab19-76c0bc72a2fe
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.
Device Characteristics
- Single Use
- Yes
- 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
- 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 |
|---|---|---|---|---|
| DJG | Enzyme Immunoassay, Opiates | Clinical Toxicology | 862.3650 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55632 | Fentanyl IVD, reagent | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850076346027 | GS1 | ||||
| Package | 10850076346024 | GS1 | Inner pack | 25 | In Commercial Distribution | |
| Package | 20850076346021 | GS1 | Case | 72 | In Commercial Distribution |
Customer Contacts
- Phone
- 713-7338088
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K251972 | 000 |