BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Biomerica

    Reg #: 2025099 · FEI: 3007981058 · Expires 2026
    View on FDA
    Products
    28
    Proprietary Names
    32
    Establishment Types
    3
    Classifications
    28

    Research this establishment in seconds

    The Research Assistant profiles FDA-registered establishments — listings, owners, related facilities — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Registration Details

    Registration Name
    Biomerica
    Registration Number
    2025099
    FEI Number
    3007981058
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    17571 Von Karman Ave
    City
    Irvine
    State
    CA
    ZIP
    92614
    Country
    US

    Regulatory Submissions

    510(k) Number
    K022660

    Owner / Operator

    Firm Name
    Biomerica, Inc.
    Operator Number
    10023649
    Address
    17571 Von Karman Ave
    City
    Irvine
    State
    CA
    Postal Code
    92614
    Country
    US

    Products

    Device Name Product Code
    Amplifier And Signal Conditioner, Biopotential DRR
    Coronavirus Antigen Detection Test System. QKP
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Helicobacter Pylori LYR
    Enzyme Immunoassay, Amphetamine DKZ
    Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) JIR
    Enzyme Immunoassay, Cocaine And Cocaine Metabolites DIO
    C-Reactive Protein, Antigen, Antiserum, And Control DCK
    Reagent, Coronavirus Serological QKO
    Gas Chromatography, Methamphetamine LAF
    Radioimmunoassay, Luteinizing Hormone CEP
    Enzyme Immunoassay, Opiates DJG
    Immunoassay Method, Troponin Subunit MMI
    Calibrator, Secondary JIT
    Radioimmunoassay, Calcitonin JKR
    Radioimmunoassay, Acth CKG
    Radioimmunoassay, Tricyclic Antidepressant Drugs LFG
    Enzyme Immunoassay, Methadone DJR
    Enzyme Immunoassay, Benzodiazepine JXM
    Kit, Test, Pregnancy, Hcg, Over The Counter LCX
    Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers LTJ
    Radioimmunoassay, Parathyroid Hormone CEW
    Enzyme Immunoassay, Cannabinoids LDJ
    Enzyme Immunoassay, Barbiturate DIS
    Assay, Erythropoietin GGT
    Enzyme Immunoassay, Phencyclidine LCM
    Reagent, Occult Blood KHE
    Visual, Pregnancy Hcg, Prescription Use JHI

    Proprietary Names

    Myoglobin ELISA COVID-19 Antigen Rapid Test (Oral Fluid) COVID-19 Antigen Rapid Test (Nasopharyngeal Swab) Aware Pad (Breast Self-Exam) Fortel Ulcer (H. pylori) Screening Test One Step Amphetamine Test Fortel Kidney Disease (Microalbumin) Screening Test One Step Cocaine Test hs C-Reactive Protein ELISA COVID-19 IgG/IgM Rapid Test One Step Ecstasy Test EZ-LH One Step Buprenorphine Test Human Cardiac Troponin I ELISA Calcitonin ELISA ACTH ELISA Kit One Step Tricyclic Antidepressants One Step Methadone Test One Step Benzodiazepines Test GAP IgG ELISA Hp Detect Stool Antigen ELISA Fortel Ultra Sensitive Pregnancy Midstream Test Fortel Prostate (PSA) Screening Test One Step Methamphetamine Test Intact-PTH ELISA One Step THC Test One Step Barbiturates Test EPO ELISA One Step Phencyclidine Test EZ Detect One Step Opiates Test EZ-HCG

    Establishment Types

    Repack or Relabel Medical Device Manufacture Device in the United States for Export Only Manufacture Medical Device