ACTIVELAST SEEN IN FEDERAL DATA AUG 2026 · 3 SOURCES
Operating signal within 12 months from two or more independent sources.
Their homepage, crawled JUL 2026
What they make
In-Vitro Diagnostic Substance Manufacturing325413Healgen is a developer and manufacturer of in-vitro diagnostic testing products. The company makes rapid diagnostic test kits for COVID-19, influenza, fentanyl, and multi-drug screening, using materials including oral fluid devices and urine test cups. Healgen serves human health and animal health industries. The company holds FDA 510(k) clearance for multiple products, FDA De Novo clearance for its COVID-19/Flu A&B Antigen Test for over-the-counter use, and CLIA waiver status for certain products including its Fentanyl FIA Test Kit.
SUMMARIZED FROM THE COMPANY’S OWN WEBSITE
Products
Made or handled here · 77
Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) · Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method · Analyzer, Chemistry (Photometric, Discrete), For Clinical Use · Analyzer, Enzyme, For Clinical Use · Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus · Antigens, All Groups, Streptococcus Spp. · Automated Urinalysis System · Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) · Blood, Occult, Colorimetric, In Urine · Clinical Sample Concentrator · Colorimeter, Photometer, Spectrophotometer For Clinical Use · Container, Specimen, Non-Sterile · Control, Fecal Occult Blood · Coronavirus Antigen Detection Test System. · Covid-19 Multi-Analyte Antigen Device · Device, Fertility Diagnostic, Proceptive · Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) · Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) · Dye-Indicator, Ph (Urinary, Non-Quantitative) · Enzyme Immunoassay, Amphetamine · Enzyme Immunoassay, Barbiturate · Enzyme Immunoassay, Benzodiazepine · Enzyme Immunoassay, Cannabinoids · Enzyme Immunoassay, Cocaine And Cocaine Metabolites · Enzyme Immunoassay, Methadone · Enzyme Immunoassay, Nicotine And Nicotine Metabolites · Enzyme Immunoassay, Opiates · Enzyme Immunoassay, Phencyclidine · Enzyme Immunoassay, Propoxyphene · Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use · Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua · Gas Chromatography, Methamphetamine · Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) · Kit, Direct Antigen, Negative Control · Kit, Direct Antigen, Positive Control · Kit, Test, Pregnancy, Hcg, Over The Counter · Method, Enzymatic, Glucose (Urinary, Non-Quantitative) · Multi-Analyte Respiratory Virus Antigen Detection Test · Nephelometer, For Clinical Use · Nitroprusside, Ketones (Urinary, Non-Quant.) · Over-The-Counter Covid-19 Antigen Test · Paper, Obstetric Ph · Radioimmunoassay, Tricyclic Antidepressant Drugs · Reagent, Coronavirus Serological · Reagent, Occult Blood · Reagents, 2019-Novel Coronavirus Nucleic Acid · Refractometer For Clinical Use · Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings · Test, Amphetamine, Employment And Insurance Testing, Exempt · Test, Amphetamine, Over The Counter · Test, Barbiturate, Employment And Insurance Testing, Exempt · Test, Barbiturate, Over The Counter · Test, Benzodiazepine, Employment And Insurance Testing, Exempt · Test, Benzodiazepine, Over The Counter · Test, Cannabinoid, Employment And Insurance Testing, Exempt · Test, Cannabinoid, Over The Counter · Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt · Test, Cocaine And Cocaine Metabolites, Over The Counter · Test, Codeine, Employment And Insurance Testing, Exempt · Test, Follicle Stimulating Hormone (Fsh), Over The Counter · Test, Luteinizing Hormone (Lh), Over The Counter · Test, Methadone, Employment And Insurance Testing, Exempt · Test, Methadone, Over The Counter · Test, Methamphetamine, Employment And Insurance Testing, Exempt · Test, Methamphetamine, Over The Counter · Test, Methaqualone, Employment And Insurance Testing, Exempt · Test, Morphine, Employment And Insurance Testing, Exempt · Test, Opiates, Employment And Insurance Testing, Exempt · Test, Opiates, Over The Counter · Test, Phencyclidine (Pcp), Over The Counter · Test, Propoxyphene, Employment And Insurance Testing, Exempt · Test, Propoxyphene, Over The Counter · Test System, Nicotine, Cotinine, Metabolites · Test, Tricyclic Antidepressant Drugs, Employment And Insurance Testing, Exempt · Test, Tricyclic Antidepressants, Over The Counter · Test, Urine Leukocyte · Thin Layer Chromatography, MethamphetamineWhere these came from
77 from FDA device registration · Federal registry
FDA device establishment 3009238284, product code JMA; proprietary names: Healgen Scientific LLC Healgen 500 Urine Analyzer {Tanner Scientific 10 Reagent Strips for Urinalysis}, UR
Where it is
29.61217, -95.36160 · CENSUS TIGER
Other plants nearby
| Facility | City | Industry | Status | Distance |
|---|---|---|---|---|
| Lonza Houston | Houston | Biological Product (except Diagnostic) Manufacturing 325414 | UNVERIFIED | 4.6 KM |
| SOFIE - Houston | Houston | Pharmaceutical Preparation Manufacturing 325412 | LIKELY ACTIVE | 8.2 KM |
| Wells Pharma of Houston LLC | Houston | Pharmaceutical Preparation Manufacturing 325412 | ACTIVE | 8.1 KM |
| South Texas Nuclear Pharmacy, INC. | Houston | Pharmaceutical Preparation Manufacturing 325412 | ACTIVE | 8.6 KM |
| Houston | Houston | Corrugated and Solid Fiber Box Manufacturing 322211 | LIKELY ACTIVE | 9.2 KM |
Also at this address
1 other record shares this street address. Separate filings can describe distinct businesses on one site, or the same plant recorded by different agencies, so every record is kept rather than merged away.
WHERE THIS RECORD COMES FROM — 3 FEDERAL SOURCES, 9 FIELDS
Every fact on this page traces to a public federal filing. The table below names which register holds this facility, whether that register proves the plant operates or only that it exists, and when each of them last saw it.
| Source | Evidence | First seen | Last seen |
|---|---|---|---|
| FDA DEVICES | OPERATING | AUG 2026 | AUG 2026 |
| COMPANY SITE | OPERATING | JUL 2026 | AUG 2026 |
| SAM GOV | OPERATING | FEB 2026 | FEB 2026 |
FIELD BY FIELD — WHICH SOURCE SUPPLIED WHAT
| FIELD | SOURCE | SIGNAL |
|---|---|---|
| ADDRESS LINE1 | SAM GOV | FEB 2026 |
| CAGE CODE | SAM GOV | FEB 2026 |
| CITY | SAM GOV | FEB 2026 |
| GEOM | CENSUS GEOCODER | JUL 2026 |
| NAME | SAM GOV | FEB 2026 |
| REGISTRATION EXPIRATION | SAM GOV | FEB 2026 |
| STATE | SAM GOV | FEB 2026 |
| WEBSITE | SAM GOV | FEB 2026 |
| YEAR ESTABLISHED | SITE YEAR | AUG 2026 |
Status is computed from independent sources; nothing here is self-reported unless marked Claimed.