BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HOME HEALTH US INCORPORATED

    Reg #: 3021186226 · FEI: 3021186226 · Expires 2026
    View on FDA
    Products
    52
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    52

    Registration Details

    Registration Name
    HOME HEALTH US INCORPORATED
    Registration Number
    3021186226
    FEI Number
    3021186226
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    7672 15th St E
    City
    Sarasota
    State
    FL
    ZIP
    34243
    Country
    US

    Regulatory Submissions

    510(k) Number
    K222472

    Owner / Operator

    Firm Name
    Home Health US Inc
    Operator Number
    10083434
    Address
    7672 15th Street E
    City
    Sarasota
    State
    FL
    Postal Code
    34243
    Country
    US
    Correspondent
    Luca J Hanson

    Products

    Device Name Product Code
    Test, Follicle Stimulating Hormone (Fsh), Over The Counter NGA
    Enzymatic Esterase--Oxidase, Cholesterol CHH
    Test, Luteinizing Hormone (Lh), Over The Counter NGE
    Nitroprusside, Ketones (Urinary, Non-Quant.) JIN
    Container, Specimen, Non-Sterile NNI
    Multiple Use Blood Lancet For Single Patient Use Only QRL
    Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature QRK
    Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) JJB
    Dye-Indicator, Ph (Urinary, Non-Quantitative) CEN
    Reagent, Occult Blood KHE
    Acid, Uric, Uricase (Colorimetric) KNK
    System, Test, Automated Blood Grouping And Antibody KSZ
    Thin Layer Chromatography, Methamphetamine DJC
    Enzyme Immunoassay, Methadone DJR
    Enzyme Immunoassay, Cannabinoids LDJ
    Thin Layer Chromatography, Morphine DNK
    Enzyme Immunoassay, Cocaine And Cocaine Metabolites DIO
    Test, Benzodiazepine, Over The Counter NFV
    Test, Methamphetamine, Over The Counter NGG
    Gas Chromatography, Methamphetamine LAF
    Test, Cannabinoid, Over The Counter NFW
    Enzyme Immunoassay, Opiates DJG
    Test, Phencyclidine (Pcp), Over The Counter NGM
    Test, Methadone, Over The Counter PTG
    Radioimmunoassay, Tricyclic Antidepressant Drugs LFG
    Test, Tricyclic Antidepressants, Over The Counter QAW
    Test, Opiates, Over The Counter NGL
    Test, Amphetamine, Over The Counter NFT
    Enzyme Immunoassay, Phencyclidine LCM
    Enzyme Immunoassay, Benzodiazepine JXM
    Enzyme Immunoassay, Barbiturate DIS
    Test, Morphine, Over The Counter NGI
    Test, Barbiturate, Over The Counter PTH
    Enzyme Immunoassay, Amphetamine DKZ
    Test, Cocaine And Cocaine Metabolites, Over The Counter NFY
    Needle, Hypodermic, Single Lumen FMI
    Continuous Measurement Thermometer FLL
    Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) JMA
    Container, Specimen Mailer And Storage, Sterile KDT
    Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) JMT
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Immunoassay, Pregnanediol Glucuronide, Over The Counter QKE
    Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) JIR
    Blood, Occult, Colorimetric, In Urine JIO
    Test, Urine Leukocyte LJX
    Method, Enzymatic, Glucose (Urinary, Non-Quantitative) JIL
    Refractometer For Clinical Use JRE
    Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) CDM
    Kit, Test, Pregnancy, Hcg, Over The Counter LCX
    Paper, Obstetric Ph LNW
    Test, Propoxyphene, Over The Counter QBF
    Enzyme Immunoassay, Propoxyphene JXN

    Proprietary Names

    One Step® ELDONCARD One Step Infrared Thermometer DET-3017

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198