FDA.reportPublic FDA data

HEALGEN LIFE SCIENCE LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30383713353038371335HEALGEN LIFE SCIENCE LLC1Y2026-01-013818 Fuqua St Houston TX US 77047

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00850076346010Healgen - 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.713-7338088bryan.fang@healgen.com
00850076346027Healgen - 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.713-7338088bryan.fang@healgen.com
10850076346017Healgen - 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.713-7338088bryan.fang@healgen.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3392611956609105K251972Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180)DJG2025-08-15

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DJG12025-08-15

GUDID#