BEUDAMED
    FDA Registration Active 🇺🇸 United States

    LUMIQUICK DIAGNOSTICS, INC.

    Reg #: 3005984081 · FEI: 3005984081 · Expires 2026
    View on FDA
    Products
    59
    Proprietary Names
    16
    Establishment Types
    6
    Classifications
    58

    Registration Details

    Registration Name
    LUMIQUICK DIAGNOSTICS, INC.
    Registration Number
    3005984081
    FEI Number
    3005984081
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    2946 SCOTT BLVD.
    City
    SANTA CLARA
    State
    CA
    ZIP
    95054
    Country
    US

    Regulatory Submissions

    510(k) Number
    K003809

    Owner / Operator

    Firm Name
    LUMIQUICK DIAGNOSTICS, INC.
    Operator Number
    9093981
    Address
    2946 SCOTT BLVD., --
    City
    Santa Clara
    State
    CA
    Postal Code
    95054
    Country
    US
    Correspondent
    Chih C Wang

    Products

    Device Name Product Code
    Enzyme Immunoassay, Opiates DJG
    Enzyme Immunoassay, Amphetamine DKZ
    Enzyme Immunoassay, Benzodiazepine JXM
    Thin Layer Chromatography, Methamphetamine DJC
    Enzyme Immunoassay, Cocaine And Cocaine Metabolites DIO
    Enzyme Immunoassay, Cannabinoids LDJ
    Radioimmunoassay, Testosterones And Dihydrotestosterone CDZ
    Enzyme Immunoassay, Methadone DJR
    Enzyme Immunoassay, Phencyclidine LCM
    Enzyme Immunoassay, Barbiturate DIS
    System, Test, Beta-2-Microglobulin Immunological JZG
    NED
    Antigens, All Groups, Streptococcus Spp. GTY
    Zika Virus Serological Reagents (Emergency Use) PYS
    Reagent, Coronavirus Serological QKO
    Enzyme Linked Immunoabsorbent Assay, Rotavirus LIQ
    Test, Methamphetamine, Over The Counter NGG
    Test, Cannabinoid, Over The Counter NFW
    Test, Barbiturate, Over The Counter PTH
    Test, Cocaine And Cocaine Metabolites, Over The Counter NFY
    Test, Benzodiazepine, Over The Counter NFV
    Test, Opiates, Over The Counter NGL
    Test, Methadone, Over The Counter PTG
    Test, Propoxyphene, Over The Counter QBF
    Test, Amphetamine, Over The Counter NFT
    Test, Tricyclic Antidepressants, Over The Counter QAW
    Legionella, Spp., Elisa MJH
    Radioimmunoassay, Prolactin (Lactogen) CFT
    Radioimmunoassay, Thyroid-Stimulating Hormone JLW
    Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers LTJ
    Test Reagents For Ethyl Alcohol DMJ
    Ferritin, Antigen, Antiserum, Control DBF
    Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. GNC
    Test, Qualitative, Detection Of Dengue Igm And Igg Antibodies NWY
    Reagent, Occult Blood KHE
    Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine KLI
    Thin Layer Chromatography, Barbiturate DKX
    Coronavirus Antigen Detection Test System. QKP
    Kit, Test, Pregnancy, Hcg, Over The Counter LCX
    Replacement, Ossicular Prosthesis, Total ETA
    Radioimmunoassay, Total Triiodothyronine CDP
    Atp And Creatine Kinase (Enzymatic), Creatine JLB
    Gas Chromatography, Methamphetamine LAF
    Devices Detecting Influenza A, B, And C Virus Antigens PSZ
    Visual, Pregnancy Hcg, Prescription Use JHI
    Radioimmunoassay, Follicle-Stimulating Hormone CGJ
    C-Reactive Protein, Antigen, Antiserum, And Control DCK
    Radioimmunoassay, Tricyclic Antidepressant Drugs LFG
    Enzyme Immunoassay, Propoxyphene JXN
    Thin Layer Chromatography, Morphine DNK
    Thin Layer Chromatography, Propoxyphene DPN
    Helicobacter Pylori LYR
    Ige, Antigen, Antiserum, Control DGC
    Applicator, Absorbent Tipped, Sterile KXG
    Biosensor, Immunoassay, Myoglobin MVE
    Immunoassay Method, Troponin Subunit MMI
    Antigens, Cf (Including Cf Control), Adenovirus 1-33 GOD
    Radioimmunoassay, Luteinizing Hormone CEP
    Amplifier And Signal Conditioner, Biopotential DRR

    Proprietary Names

    SARS-CoV-2 Antibody Test Card QuickProfile S. typhi IgG/IgM Duo Test QuickProfile Rapid Urine Fentanyl (FTL) Test DipCard QuickProfile Rapid Urine Fentanyl (FTL) Test Card QuickProfile Rapid Urine Fentanyl (FTL) Test Strip Rapid SARS-CoV-2 Antigen Test Card - for lay use Rapid SARS-CoV-2 Antigen Test Card - Outside a hospital other clinical setting Rapid SARS-CoV-2 Antigen Test Card Rapid SARS-CoV-2 Antigen Test Card - in community Rapid SARS-CoV-2 Antigen Test Card - a combination of clinical and non-clinical settings Rapid SARS-CoV-2 Antigen Test Card - for person use QuickProfile HCG Tests QuickProfile™ HCG Test Strip QuickProfile Rapid Single/Multi-Drug Test Cup QuickProfile Rapid Single/Multi-Drug Test DipCard QuickProfile

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device Manufacture Device in the United States for Export Only Reprocess Single-Use Device Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device for Another Party (Contract Manufacturer)