BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HEALGEN SCIENTIFIC LLC

    Reg #: 3009238284 · FEI: 3009238284 · Expires 2026
    View on FDA
    Products
    75
    Proprietary Names
    45
    Establishment Types
    3
    Classifications
    75

    Registration Details

    Registration Name
    HEALGEN SCIENTIFIC LLC
    Registration Number
    3009238284
    FEI Number
    3009238284
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    3818 Fuqua St
    City
    Houston
    State
    TX
    ZIP
    77047
    Country
    US

    Regulatory Submissions

    510(k) Number
    K253705

    Owner / Operator

    Firm Name
    HEALGEN SCIENTIFIC LLC
    Operator Number
    10038461
    Address
    3818 Fuqua Street
    City
    Houston
    State
    TX
    Postal Code
    77047
    Country
    US

    Products

    Device Name Product Code
    Clinical Sample Concentrator JJH
    Covid-19 Multi-Analyte Antigen Device QMN
    Enzyme Immunoassay, Cannabinoids LDJ
    Enzyme Immunoassay, Phencyclidine LCM
    Enzyme Immunoassay, Amphetamine DKZ
    Enzyme Immunoassay, Methadone DJR
    Thin Layer Chromatography, Methamphetamine DJC
    Enzyme Immunoassay, Opiates DJG
    Enzyme Immunoassay, Cocaine And Cocaine Metabolites DIO
    Test System, Nicotine, Cotinine, Metabolites MRS
    Test, Methaqualone, Employment And Insurance Testing, Exempt PVF
    Enzyme Immunoassay, Propoxyphene JXN
    Radioimmunoassay, Tricyclic Antidepressant Drugs LFG
    Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method DIC
    Test, Methadone, Over The Counter PTG
    Test, Phencyclidine (Pcp), Over The Counter NGM
    Test, Tricyclic Antidepressants, Over The Counter QAW
    Test, Cocaine And Cocaine Metabolites, Over The Counter NFY
    Test, Benzodiazepine, Over The Counter NFV
    Test, Opiates, Over The Counter NGL
    Test, Propoxyphene, Over The Counter QBF
    Test, Methamphetamine, Over The Counter NGG
    Test, Cannabinoid, Over The Counter NFW
    Test, Barbiturate, Over The Counter PTH
    Test, Amphetamine, Over The Counter NFT
    Test, Cannabinoid, Employment And Insurance Testing, Exempt PVJ
    Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings QVF
    Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus GQG
    Test, Urine Leukocyte LJX
    Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) JMT
    Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua QKR
    Colorimeter, Photometer, Spectrophotometer For Clinical Use JJQ
    Gas Chromatography, Methamphetamine LAF
    Enzyme Immunoassay, Benzodiazepine JXM
    Paper, Obstetric Ph LNW
    Kit, Test, Pregnancy, Hcg, Over The Counter LCX
    Container, Specimen, Non-Sterile NNI
    Antigens, All Groups, Streptococcus Spp. GTY
    Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use LXG
    Nephelometer, For Clinical Use JQX
    Enzyme Immunoassay, Barbiturate DIS
    Reagent, Occult Blood KHE
    Reagents, 2019-Novel Coronavirus Nucleic Acid QJR
    Test, Tricyclic Antidepressant Drugs, Employment And Insurance Testing, Exempt PVK
    Over-The-Counter Covid-19 Antigen Test QYT
    Nitroprusside, Ketones (Urinary, Non-Quant.) JIN
    Coronavirus Antigen Detection Test System. QKP
    Multi-Analyte Respiratory Virus Antigen Detection Test SCA
    Test, Morphine, Employment And Insurance Testing, Exempt PVG
    Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) CDM
    Dye-Indicator, Ph (Urinary, Non-Quantitative) CEN
    Analyzer, Enzyme, For Clinical Use JJI
    Test, Follicle Stimulating Hormone (Fsh), Over The Counter NGA
    Test, Amphetamine, Employment And Insurance Testing, Exempt PUX
    Test, Barbiturate, Employment And Insurance Testing, Exempt PUY
    Test, Methamphetamine, Employment And Insurance Testing, Exempt PVD
    Enzyme Immunoassay, Nicotine And Nicotine Metabolites MKU
    Device, Fertility Diagnostic, Proceptive LHD
    Refractometer For Clinical Use JRE
    Blood, Occult, Colorimetric, In Urine JIO
    Automated Urinalysis System KQO
    Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) JJB
    Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) JMA
    Method, Enzymatic, Glucose (Urinary, Non-Quantitative) JIL
    Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) JIR
    Test, Methadone, Employment And Insurance Testing, Exempt PVE
    Test, Benzodiazepine, Employment And Insurance Testing, Exempt PUZ
    Test, Opiates, Employment And Insurance Testing, Exempt PVH
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    Test, Propoxyphene, Employment And Insurance Testing, Exempt PVI
    Test, Luteinizing Hormone (Lh), Over The Counter NGE
    Control, Fecal Occult Blood OSL
    Test, Codeine, Employment And Insurance Testing, Exempt PVB
    Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt PVA
    Reagent, Coronavirus Serological QKO

    Proprietary Names

    Healgen COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab) Healgen Accurate Urine Drug Screen Dip Card Healgen Accurate Home Urine Drug Test Dip Card Healgen Accurate Home Multi-Drug Urine Test Cup Healgen Accurate Multi-Drug Urine Drug Screening Cup Healgen Accurate Multi-Drug Urine Drug Screen Cup Healgen Accurate Home Multi-Drug Urine Testing Cup Healgen Rapid Check COVID-19 Antigen Test Healgen Rapid Check RSV Antigen Test Cassette Healgen® URS Test Strips Healgen Scientific LLC Healgen PH test HEAL-CHECK Pee Cup Healgen Rapid Check Strep A Antigen Test Healgen Scientific LLC Strep A Rapid Test Strip (Throat Swab) Healgen® Accurate Fentanyl Rapid Test Cassette (Urine) Healgen® Accurate Rapid Fentanyl Test Strip (Urine) Healgen® Accurate Rapid Fentanyl Test Cassette (Urine) Healgen® Accurate Fentanyl Rapid Test Dip Card (Urine) Healgen® Accurate Fentanyl Rapid Test Strip (Urine) Healgen® Accurate Rapid Fentanyl Test Dip Card (Urine) Healgen Scientific LLC URcheck UTI Test Strip Easy Healthcare Corporation  easy@Home Urinary Tract Infection Test Healgen URS Test Strips Healgen Scientific LLC, URcheck URS Test Strip Heal-Check Rapid COVID-19 Antigen Self-Test Siemens Clinitest Healgen Scientific Healgen Rapid Check Flu A&B/COVID-19 Antigen Test Pro Healgen Rapid Check COVID-19/Flu A&B Antigen Test PRO Healgen Rapid Check COVID-19 / Flu A&B Antigen Test Healgen Rapid Check Flu A&B/COVID-19 Antigen Test Healgen Scientific LLC., FSH Menopause Test Midstream Healgen Scientific LLC., FSH Menopause Test Cassette Healgen Scientific LLC., FSH Menopause Test Strip Healgen® Accurate Oral Fluid Drug Test COT/THC Healgen® Accurate Oral Fluid Drug Test Healgen URcheck Urinalysis Reagent Strips Healgen Scientific LLC Healgen 500 Urine Analyzer {Tanner Scientific 10 Reagent Strips for Urinalysis} URcheck Urinalysis Reagent Test Strip Healgen Scientific LLC Healgen 500 Urine Analyzer Healgen® Accurate Oral Fluid Drug Test (THC + COT) Healgen Scientific LLC LH Luteinizing Hormone Test Healgen hCG Pregnancy Test Cassette Healgen hCG Pregnancy Test Strip

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device