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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 (763)
Page 3 of 16| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Cortisol Quantitative Test Kit (Time-Resolved FIA) | FKCOR-302a | EUDAMED | IVD General | Active |
| HCG Pregnancy Rapid Test | GAHCG-101b-1T | EUDAMED | IVD devices for self-testing | Active |
| Disposable Virus Sampling Tube (including swab) | SDVS01-AHG50E/SDVS01-BHG50E SDVS01-CHG50E/SDVS01-DHG50E | EUDAMED | IVD General | Active |
| Survival Motor Neuron Genes 1, 2 (SMN1, SMN2) Exon Deletion Detection Kit (Fluorescence Quantitative PCR Method) | N7001C | EUDAMED | IVD General | Active |
| Adenovirus Antigen Fluorescence Rapid Test Cassette (Swab) | FCADE-502Ca | EUDAMED | IVD General | Active |
| cTnI Control | FDTRO-PN20 | EUDAMED | IVD General | Active |
| Monkeypox Virus Detection Kit (Fluorescence PCR) | AMPV01-AHG48E; AMPV01-AHG96E | EUDAMED | IVD General | Active |
| Rapid Human Papillomavirus (16/18/45) DNA Test | RHPV301-AHG5E/RHPV301-AHG25E | EUDAMED | IVD General | Active |
| AMH Quantitative Test Kit (Time-Resolved FIA) | FAAMH-302a | EUDAMED | IVD General | Active |
| Free T3 Quantitative Test Kit (Time-Resolved FIA) | FKFT3-302a | EUDAMED | IVD General | Active |
| FA Control | FIFA-LP3 | EUDAMED | IVD General | Active |
| LH Ovulation Rapid Test | GALH-103b-5T | EUDAMED | IVD devices for self-testing | Active |
| SARS-CoV-2 & Influenza A/B Detection Kit (Direct Fluorescence PCR) | ACAB01-AHG48E; ACAB01-AHG96E | EUDAMED | IVD General | Active |
| Disposable Sampling Kit | SDSM01-AHG50E | EUDAMED | IVD General | Active |
| Free T3 Quantitative Test Kit (Time-Resolved FIA) | FKFT3-402a | EUDAMED | IVD General | Active |
| fT3 Control | FKFT3-PN20 | EUDAMED | IVD General | Active |
| Nucleic Acid Genotyping Kit for Human Papillomavirus 18 types (Flowcytometry Fluorescence Hybridization Method) | 2HPV18A01 | EUDAMED | IVD General | Active |
| PGI Quantitative Test Kit (Time-Resolved FIA) | FEPG(I)-302a-G16 | EUDAMED | IVD General | Active |
| Nucleic Acid Detection Kit for Reproductive Tract Infection Pathogens (9 Types)(Flowcytometry Fluorescence Hybridization Method) | 2RET9A01 | EUDAMED | IVD General | Active |
| HCG Pregnancy Rapid Test | GAHCG-103d-2T | EUDAMED | IVD devices for self-testing | Active |
| Rapid Varicella-Zoster Virus DNA Test | RNG01-AHG5E/ RNG01-AHG25E | EUDAMED | IVD General | Active |
| CK-MB Control | FDCKM-PN20 | EUDAMED | IVD General | Active |
| Influenza A&B Ag Test Kit (Time-Resolved FIA) | FCFLU(A/B)-502Fa | EUDAMED | IVD General | Active |
| Human Papillomavirus (18 types) Genotyping Kit(Melt-Fluorescence PCR) | AHPV1801-BHG48E,AHPV1801-BHG96E | EUDAMED | IVD General | Active |
| D-Dimer Control | FDDDI-PN20 | EUDAMED | IVD General | Active |
| Flu A(H5) Ag Fluorescent Rapid Test Cassette (Time-Resolved FIA) | FCFLU(AH5)-502a | EUDAMED | IVD General | Active |
| Mycoplasma Pneumoniae Detection Kit (Fluorescence PCR) | AMP01-AHG48E; AMP01-AHG96E; AMP01D-AHG48E; AMP01D-AHG96E | EUDAMED | IVD General | Active |
| HbA1c Control | FIHBA-PN20 | EUDAMED | IVD General | Active |
| IgE Quantitative Test Kit(Time-Resolved FIA) | FGIGE-302a | EUDAMED | IVD General | Active |
| In vitro Diagnostic Kit for Myoglobin (Chemiluminescence Assay) | 1MYOB01 | EUDAMED | IVD General | Active |
| Quantitative Analysis Kit for Three Tumor Markers (Flowcytometry Fluorescence Method) | 1TM3B01 | EUDAMED | IVD General | Active |
| Calcitonin Quantitative Test Kit (Time-Resolved FIA) | FECAL-402a | EUDAMED | IVD General | Active |
| LH Ovulation Rapid Test | GALH-101a-1T | EUDAMED | IVD devices for self-testing | Active |
| RSV Antigen FIA Control Kit | FCRSV-PN2 | EUDAMED | IVD General | Active |
| FSH Control | FAFSH-PN20 | EUDAMED | IVD General | Active |
| PRL Quantitative Test Kit (Time-Resolved FIA) | FAPRL-402a | EUDAMED | IVD General | Active |
| fT4 Control | FKFT4-PN20 | EUDAMED | IVD General | Active |
| HG-P320 Real-time PCR system | MRQP06-E | EUDAMED | IVD General | Active |
| HCG Pregnancy Rapid Test | GAHCG-103b-2T | EUDAMED | IVD devices for self-testing | Active |
| LH Ovulation Rapid Test | GALH-103a-2T | EUDAMED | IVD devices for self-testing | Active |
| Influenza A/B Detection Kit (Direct Fluorescence PCR) | AFAB01-AHG48E; AFAB01-AHG96E | EUDAMED | IVD General | Active |
| HCG Pregnancy Rapid Test | GAHCG-103d-25T | EUDAMED | IVD devices for self-testing | Active |
| Cortisol Control | FKCOR-PN20 | EUDAMED | IVD General | Active |
| CRP Quantitative Test Kit (Time-Resolved FIA) | FDWCR-402a | EUDAMED | IVD General | Active |
| SARS-CoV-2 Fluorescence PCR Kit (Lyophilized) | ACOV03D-AHG48E; ACOV03D-AHG96E | EUDAMED | IVD General | Active |
| Quantitative Analysis Kit for Six Tumor Markers (Flowcytometry Fluorescence Method) | 1TM6B01 | EUDAMED | IVD General | Active |
| Group A Streptococcus Detection Kit (Fluorescence PCR) | AGAS01-AHG48E; AGAS01D-AHG48E | EUDAMED | IVD General | Active |
| PCT Control | FDPCT-PN20 | EUDAMED | IVD General | Active |
| PCT/IL-6 Control | FDPI-PN20 | EUDAMED | IVD General | Active |
| Human Papillomavirus (HR 18 types) Genotyping Kit (Melt-Fluorescence PCR) | AHPV1801-CHG48E | EUDAMED | IVD General | Active |
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