BEUDAMED
    FDA Registration Active 🇺🇸 United States

    LIN-ZHI INTERNATIONAL, INC.

    Reg #: 3003610499 · FEI: 3003610499 · Expires 2026
    View on FDA
    Products
    19
    Proprietary Names
    117
    Establishment Types
    1
    Classifications
    19

    Registration Details

    Registration Name
    LIN-ZHI INTERNATIONAL, INC.
    Registration Number
    3003610499
    FEI Number
    3003610499
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2945 Oakmead Village Ct
    City
    Santa Clara
    State
    CA
    ZIP
    95051
    Country
    US

    Regulatory Submissions

    510(k) Number
    K032365

    Owner / Operator

    Firm Name
    LIN-ZHI INTERNATIONAL, INC.
    Operator Number
    9049436
    Address
    2945 Oakmead Village Court, --
    City
    Santa Clara
    State
    CA
    Postal Code
    95051
    Country
    US
    Correspondent
    MARIE LIN

    Products

    Device Name Product Code
    Drug Specific Control Materials LAS
    Enzyme Immunoassay, Benzodiazepine JXM
    Calibrators, Drug Specific DLJ
    Calibrators, Ethyl Alcohol DNN
    Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method DIC
    Alcohol Control Materials DKC
    Enzyme Immunoassay, Amphetamine DKZ
    Enzyme Immunoassay, Opiates DJG
    Enzyme Immunoassay, Methadone DJR
    Enzyme Immunoassay, Cannabinoids LDJ
    Calibrators, Drug Mixture DKB
    Gas Chromatography, Methamphetamine LAF
    Enzyme Immunoassay, Propoxyphene JXN
    Enzyme Immunoassay, Cocaine And Cocaine Metabolites DIO
    Drug Mixture Control Materials DIF
    Enzyme Immunoassay, Phencyclidine LCM
    Meprobamate Test System QBK
    Enzyme Immunoassay, Barbiturate DIS
    Enzyme Immunoassay, Nicotine And Nicotine Metabolites MKU

    Proprietary Names

    Benzodiazepine DAU Controls Benzodiazepine DAU Calibrators Benzodiazepine Enzyme Immunoassay Ethyl Alcohol DAU Calibrators Ethyl Alcohol Enzymatic Assay Ethyl Alcohol DAU Controls Methadone DAU Controls Propoxyphene DAU Calibrators Propoxyphene DAU Controls Methadone DAU Calibratos Ecstasy DAU Controls Ecstasy DAU Calibrators Ecstasy Enzyme Immunoassay LZI Fentanyl II Enzyme Immunoassay Methadone Enzyme Immunoassay Methadone Metabolite (EDDP) Enzyme Immunoassay Methadone Metabolite (EDDP) 100 DAU Calibrators Methadone Metabolite (EDDP) 300 DAU Calibrators LZI Oxycodone III Enzyme Immunoassay Buprenorphine Enzyme Immunoassay Norbuprenorphine DAU Controls Norbuprenorphine DAU Calibrator LZI Methadone II Enzyme Immunoassay LZI Fentanyl III Enzyme Immunoassay Oral Fluid Cannabinoids (OF THC) Controls Oral Fluid Cannabinoids (OF THC) Calibrators Oral Fluid Cannabinoid Enzyme Immunoassay Methadone Metabolite DAU Calibrators Methadone Metabolite DAU Controls Methadone Metabolite Enzyme Immunoassay Phencyclidine DAU Controls Cocaine Metabolite DAU Controls Amphetamines DAU Controls Opiate DAU Calibrators Amphetamines DAU Calibrators Opiate DAU Controls Cocaine Metabolite DAU Calibrators Phencyclidine DAU Calibrators Norfentanyl DAU Calibrator LZI Methadone II Calibrators (Urine) LZI Oxycodone (300) Calibrators (Urine) Carisprodol Metabolite (Meprobamate) DAU Calibrators LZI Tramadol Calibrators (Urine) LZI Cotinine II Calibrators (Urine) LZI Oxycodone (100) Calibrators (Urine) LZI Fentanyl Calibrator Multi-Analyte Set F Drug of Abuse Calibrators Multi-Analyte Set D Drug of Abuse Calibrators Multi-Analyte Set E Drug of Abuse Calibrators Methamphetamine Enzyme Immunoassay Methamphetamine DAU Calibrators Methamphetamine DAU Controls 6-Acetylmorphine DAU Calibrators 6-Acetylmorphine DAU Controls 6-Acetylmorphine Enzyme Immunoassay Opiate 2000 DAU Calibrators Opiate 2000 DAU Controls Opiate 2000 Enzyme Immunoassay Propoxyphene Enzyme Immunoassay Opiate Enzyme Immunoassay Oxycodone Enzyme Immunoassay Oxycodone DAU Calibrators Oxycodone DAU Controls Amphetamines Enzyme Immunoassay Amphetamines 500 DAU Calibrators Amphetamines 500 DAU Controls Amphetamines 500 Enzyme Immunoassay Fentanyl Enzyme Immunoassay Cocaine Metabolite 150 DAU Controls Cocaine Metabolite 150 DAU Calibrators Cocaine Metabolite 150 Enzyme Immunoassay Multi-Analyte Set A Urine Drug of Abuse Calibrators Multi-Analyte Set C Urine Drug of Abuse Calibrators Multi-Analyte Set A Urine Drug of Abuse Controls Multi-Analyte Set C Urine Drug of Abuse Controls Multi-Analyte Set B Urine Drug of Abuse Controls Multi-Analyte Set B Urine Drug of Abuse Calibrators LZI Tramadol Enzyme Immunoassay Phencyclidine Enzyme Immunoassay Oral Fluid 6-Acetylmorphine Controls Oral Fluid 6-Acetylmorphine Calibrators Oral Fluid 6-Acetylmorphine Enzyme Immunoassay Oral Fluid Amphetamine Calibrators Oral Fluid Amphetamine Enzyme Immunoassay Oral Fluid Amphetamine Controls Carisprodol Metabolite (Meprobamate) DAU Controls Methadone Metabolite 100 DAU Controls LZI Methadone II Controls (Urine) Methadone Metabolite 300 DAU Controls LZI Cotinine II Controls (Urine) Norfentanyl DAU Controls LZI Oxycodone (100) Controls (Urine) LZI Tramadol Controls (Urine) LZI Oxycodone (300) Controls (Urine) LZI Fentanyl Controls Multi-Analyte Set E Urine Drug of Abuse Controls Multi-Analyte Set D Urine Drug of Abuse Controls Multi-Analyte Set F Urine Drug of Abuse Controls DAT Opiates Multi Control I Set Oral Fluid Methamphetamine Calibrators Oral Fluid Methamphetamine Enzyme Immunoassay Oral Fluid Methamphetamine Controls Cannabinoid DAU Calibrators Cannabinoid DAU Controls Cannabinoid Enzyme Immunoassay Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay Cocaine Metabolite Enzyme Immunoassay Barbiturate DAU Calibrators Barbiturate DAU Controls Barbiturate Enzyme Immunoassay Hydrocodone 300 DAU Controls Hydrocodone 100 DAU Controls Hydrocodone 300 DAU Calibrators Hydrocodone 300 Enzyme Immunoassay Hydrocodone 100 Enzyme Immunoassay Hydrocodone 100 DAU Calibrators LZI Cotininel II Enzyme Immunoassay

    Establishment Types

    Manufacture Medical Device