healgen.comHealgen - 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.
2026-02-06
HEALGEN LIFE SCIENCE LLC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3038371335 | 3038371335 | HEALGEN LIFE SCIENCE LLC | 1 | Y | 2026-01-01 | 3818 Fuqua St Houston TX US 77047 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00850076346010 | Healgen - 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. | 713-7338088 | bryan.fang@healgen.com |
| 00850076346027 | Healgen - 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. | 713-7338088 | bryan.fang@healgen.com |
| 10850076346017 | Healgen - 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. | 713-7338088 | bryan.fang@healgen.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 339261 | 1956609105 | K251972 | Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180) | DJG | 2025-08-15 |
| 339261 | 1267320770 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| DJG | 1 | 2025-08-15 |
GUDID#
Healgen - 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.
2026-02-06
Healgen - 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.
2026-02-06