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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 (779)
Page 2 of 16| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| 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 |
| NGAL Control | FINGA-PN20 | EUDAMED | IVD General | Active |
| Myo Control | FDMYO-PN20 | EUDAMED | IVD General | Active |
| LH Ovulation Rapid Test | GALH-102a-10T | EUDAMED | IVD devices for self-testing | Active |
| HG-N32 Nucleic Acid Purification System | MNAP01 | EUDAMED | IVD General | Active |
| HCG Pregnancy Rapid Test | GAHCG-103b-1T | EUDAMED | IVD devices for self-testing | Active |
| In vitro Diagnostic Kit for Creatine Kinase-MB (Chemiluminescence Assay) | 1CKMBB02 | EUDAMED | IVD General | Active |
| SARS-CoV-2 Detection Kit (Direct Fluorescence PCR） | ACOV01-AHG48E; ACOV01-AHG96E | EUDAMED | IVD General | Active |
| CT Control | FDCT-PN20 | EUDAMED | IVD General | Active |
| Herpes Simplex VirusⅡDetection Kit (Fluorescence PCR) | AHSV201-AHG48E; AHSV201-AHG96E; AHSV201D-AHG48E; AHSV201D-AHG96E | EUDAMED | IVD General | Active |
| LH Ovulation Rapid Test | GALH-103a-1T | EUDAMED | IVD devices for self-testing | Active |
| Dengue Virus Fluorescence PCR Kit (Lyophilized) | ADV01D-AHG48E; ADV01D-AHG96E | EUDAMED | IVD General | Active |
| PTH Control | FKPTH-PN20 | EUDAMED | IVD General | Active |
| Hair Drug Test Kit (Time-Resolved FIA) | FBXXX-1102/FBDOA-11X5 | EUDAMED | IVD General | Active |
| RSV/Adenovirus Antigen Combo Fluorescence Rapid Test Cassette (Swab) | FCRA-T502a | EUDAMED | IVD General | Active |
| BNP Control | FDBNA-PN20 | EUDAMED | IVD General | Active |
| LH Ovulation Rapid Test | GALH-103a-10T | EUDAMED | IVD devices for self-testing | Active |
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