Is this your brand? Sign in to claim ownership.
Sign in to claim this brandHealgen Scientific Limited Liability Company
United States·US-MF-000018839
Last updated May 27, 2026
What Healgen Scientific Limited Liability Company makes
Healgen Scientific Limited Liability Company manufactures in vitro diagnostic (IVD) devices for clinical, rapid, and self-testing use, including kits for detecting drugs of abuse, respiratory viruses, and luteinizing hormone (LH). Their portfolio also includes quantitative test kits for biomarkers like HbA1c, thyroid hormones (T3), and vitamin D metabolites, as well as rapid antigen tests for conditions such as tuberculosis and hantavirus. Colorimetric urine analyte tests and fluorescence-based PCR kits for Mycobacterium tuberculosis are also part of their offerings.
The company’s IVD devices are classified under EU Class II and FDA’s In Vitro Diagnostic (IVD) categories, including self-testing devices and certain unclassified (U) products. These devices are registered in the EU’s EUDAMED database and the FDA’s Unique Device Identifier (UDI) system. Healgen Scientific Limited Liability Company is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 3818, Fuqua Street, Houston, TX, United States
- Website
- healgen.com
- —
- —
- [email protected]
- Phone
- 7137338088
- PRRC Contact
- Seyfried Li
- EUDAMED SRN
- US-MF-000018839
- FDA FEI Number
- —
- DUNS Number
- 031802328
Catalogue (722)
Page 1 of 15| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| D-Dimer Quantitative Test Kit (Time-Resolved FIA) | FDDDI-402a | EUDAMED | IVD General | Active |
| HbA1c Quantitative Test Kit (Time-Resolved FIA) | FIHBA-402a | EUDAMED | IVD General | Active |
| LH Control | FALH-PN20 | EUDAMED | IVD General | Active |
| Hantavirus IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) | GCHV(IgG/IgM)-402a | EUDAMED | IVD General | Active |
| T3 Control | FKTT3-PN20 | EUDAMED | IVD General | Active |
| Mycobacterium Tuberculosis Complex Fluorescence PCR Kit (Lyophilized) | AMTBC01D-AHG48E, AMTBC01D-AHG96E | EUDAMED | IVD General | Active |
| 25-OH-VD Control | FIVD-PN20 | EUDAMED | IVD General | Active |
| Adenovirus Antigen FIA Control Kit | FCADE-PN2 | EUDAMED | IVD General | Active |
| AFP Quantitative Test Kit (Time-Resolved FIA) | FEAFP-302a | EUDAMED | IVD General | Active |
| SHBG Quantitative Test Kit (Time-Resolved FIA) | FKSHB-402a | EUDAMED | IVD General | Active |
| HCG Pregnancy Rapid Test | GAHCG-103d-5T | EUDAMED | IVD devices for self-testing | Active |
| PTH Quantitative Test Kit (Time-Resolved FIA) | FKPTH-402a | EUDAMED | IVD General | Active |
| PROG Quantitative Test Kit (Time-Resolved FIA) | FAPRO-402a | EUDAMED | IVD General | Active |
| LH Ovulation Rapid Test | GALH-101a-5T | EUDAMED | IVD devices for self-testing | Active |
| Nucleic Acid Detection Kit for Respiratory Tract Infection Pathogens (8 Types)(Flowcytometry Fluorescence Hybridization Method) | 2RYT8A01 | EUDAMED | IVD General | Active |
| LH Ovulation Rapid Test | GALH-101a-10T | EUDAMED | IVD devices for self-testing | Active |
| Inflammatory Markers Control | FDINF-LP3 | EUDAMED | IVD General | Active |
| HCG Pregnancy Rapid Test | GAHCG-103b-25T | EUDAMED | IVD devices for self-testing | Active |
| LH Ovulation Rapid Test | GALH-102b-10T | EUDAMED | IVD devices for self-testing | Active |
| Treponema Pallidum Detection Kit (Fluorescence PCR) | ATP01-AHG48E/ATP01-AHG96E/ATP01D-AHG48E/ATP01D-AHG96E | EUDAMED | IVD General | Active |
| PROG Control | FAPRO-PN20 | EUDAMED | IVD General | Active |
| Treponema Pallidum Fluorescence PCR Kit (Lyophilized) | ATP01D-AHG48E/ATP01D-AHG96E | EUDAMED | IVD General | Active |
| Influenza A Virus and H5 Subtype Fluorescence PCR Kit (Lyophilized) | AIAH501D-AHG48E; AIAH501D-AHG96E | EUDAMED | IVD General | Active |
| HCG Pregnancy Rapid Test | GAHCG-102b-2T | EUDAMED | IVD devices for self-testing | Active |
| E2 Control | FAE2-PN20 | EUDAMED | IVD General | Active |
| PCT/CRP Control | FDPC-LP3 | EUDAMED | IVD General | Active |
| Beta-HCG Control | FAHCG-PN20 | EUDAMED | IVD General | Active |
| TSH Quantitative Test Kit (Time-Resolved FIA)-20ul | FKTSH-402b | EUDAMED | IVD General | Active |
| LH Ovulation Rapid Test | GALH-102b-25T | EUDAMED | IVD devices for self-testing | Active |
| Herpes Simplex VirusⅠDetection Kit (Fluorescence PCR) | AHSV101-AHG48E; AHSV101-AHG96E; AHSV101D-AHG48E; AHSV101D-AHG96E | EUDAMED | IVD General | Active |
| LH Ovulation Rapid Test | GALH-103b-10T | EUDAMED | IVD devices for self-testing | Active |
| SAA QuantitativeTest Kit (Time-Resolved FIA) | FDSAA-402a | EUDAMED | IVD General | Active |
| CRP Control | FDWCR-PN20 | EUDAMED | IVD General | Active |
| In vitro Diagnostic Kit for High sensitivity Troponin T (Chemiluminescence Assay) | 1CTNTB02 | EUDAMED | IVD General | Active |
| HCG Pregnancy Rapid Test | GAHCG-102d-5T | EUDAMED | IVD devices for self-testing | Active |
| LH Ovulation Rapid Test | GALH-101b-1T | EUDAMED | IVD devices for self-testing | Active |
| HCG Pregnancy Rapid Test | GAHCG-101b-5T | EUDAMED | IVD devices for self-testing | Active |
| TSH Control | FITSH-PN20 | EUDAMED | IVD General | Active |
| cTnI Quantitative Test Kit (Time-Resolved FIA) | FDTRO-402b | EUDAMED | IVD General | Active |
| VB12 Control | FIVB12-LP3 | EUDAMED | IVD General | Active |
| CRP / SAA Quantitative Test Kit (Time-Resolved FIA) | FDCS-T402a | EUDAMED | IVD General | Active |
| Free T4 Quantitative Test Kit (Time-Resolved FIA) | FKFT4-402a | EUDAMED | IVD General | Active |
| Monkeypox Virus Fluorescence PCR Kit (Lyophilized) | AMPV01D-AHG48E; AMPV01D-AHG96E | EUDAMED | IVD General | Active |
| RSV Antigen Fluorescent Rapid Test Cassette (Swab) | FCRSV-502a | EUDAMED | IVD General | Active |
| Survival Motor Neuron Genes 1, 2 (SMN1, SMN2) Exon Deletion Detection Kit (Fluorescence Quantitative PCR Method) | N7001D | EUDAMED | IVD General | Active |
| Cortisol Quantitative Test Kit (Time-Resolved FIA) | FKCOR-402a | EUDAMED | IVD General | Active |
| PGII Quantitative Test Kit (Time-Resolved FIA) | FEPG(II)-302a-G16 | EUDAMED | IVD General | Active |
| Gene Scoper | MFIA02-E | EUDAMED | IVD General | Active |
| Myo Quantitative Test Kit (Time-Resolved FIA) | FDMYO-402a | EUDAMED | IVD General | Active |
| β2-MG Quantitative Test Kit (Time-Resolved FIA) | FIMG-402a | EUDAMED | IVD General | Active |
Related Companies
Authorised Representatives
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.