HEALGEN LIFE SCIENCE LLC

FDA Device Registration & Listing · Houston, TX, US · Registration 3038371335

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3038371335
FEI Number
3038371335
Entity Name
HEALGEN LIFE SCIENCE LLC
City/State/Country
Houston, TX, US
Establishment Address
3818 Fuqua St, Houston, TX 77047, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Healgen Life Science LLC (Owner Number: 10093264)
Owner / Operator Contact Address
3818 Fuqua St, Houston, TX 77047, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Healgen AccuFluor Fentanyl Fluorescence Immunoassay (FIA) Test Kit - Qualitative Healgen Immunofluorescence Analyzer OG-H180

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KHO Fluorometer, For Clinical Use Clinical Chemistry Class 1 862.2560 2025-11-19
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2025-11-19
OSL Control, Fecal Occult Blood Hematology Class 2 864.6550 2026-06-09

Official Correspondent

Jianqiu Fang

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Healgen Life Science LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K153050 Co-Innovation Biotech Co., Ltd. Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard 2016-04-26
K151478 Guangzhou Wondfo Biotech Co., Ltd. Wondfo CR3 Keyless Split Sample Cup 2015-07-01
K150179 Guangzhou Wondfo Biotech Co., Ltd. CR3 Keyless Split Sample Cup Oxycodone - Cannabinoids 2015-02-25
K112310 Guangzhou Wondfo Biotech Co., Ltd. WONDFO METHADONE URINE TEST,OPIATE TEST 2011-09-08
K093175 Guangzhou Wondfo Biotech Co., Ltd. WONDFO ONE STEP BUPRENORPHINE URINE TEST, OXYCODONE URINE TEST, PROPOXPHENE URINE TEST, MULTIPLE DRUG OF ABUSE URINE TES 2010-08-25

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038371335. Last updated year: 2026. Please use registration number 3038371335 when referencing this establishment in official correspondence.
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