BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ALFA WASSERMANN

    Reg #: 2247288 · FEI: 1000122044 · Expires 2026
    View on FDA
    Products
    37
    Proprietary Names
    58
    Establishment Types
    4
    Classifications
    37

    Registration Details

    Registration Name
    ALFA WASSERMANN
    Registration Number
    2247288
    FEI Number
    1000122044
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    4 Henderson Dr
    City
    West Caldwell
    State
    NJ
    ZIP
    07006
    Country
    US

    Regulatory Submissions

    510(k) Number
    K113437

    Owner / Operator

    Firm Name
    Alfa Wassermann Diagnostic Technologies, LLC
    Operator Number
    10028192
    Address
    4 Henderson Drive
    City
    West Caldwell
    State
    NJ
    Postal Code
    07006
    Country
    US
    Correspondent
    Allan Gennis

    Products

    Device Name Product Code
    Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine KLI
    Ferritin, Antigen, Antiserum, Control DBF
    Radioassay, Triiodothyronine Uptake KHQ
    Assay, Glycosylated Hemoglobin LCP
    System, Test, Low Density, Lipoprotein MRR
    Calibrator, Primary JIS
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl LBS
    Enzymatic Esterase--Oxidase, Cholesterol CHH
    Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides CDT
    Hexokinase, Glucose CFR
    Electrode, Ion Specific, Sodium JGS
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    Electrode, Ion-Specific, Chloride CGZ
    Electrode, Ion Specific, Potassium CEM
    Nadh Oxidation/Nad Reduction, Ast/Sgot CIT
    Nadh Oxidation/Nad Reduction, Alt/Sgpt CKA
    Saccharogenic, Amylase CIJ
    Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes CJE
    Enzymatic, Carbon-Dioxide KHS
    Photometric Method, Magnesium JGJ
    Diazo Colorimetry, Bilirubin CIG
    Ferrozine (Colorimetric) Iron Binding Capacity JMO
    Photometric Method, Iron (Non-Heme) JIY
    Lipase-Esterase, Enzymatic, Photometric, Lipase CHI
    Alkaline Picrate, Colorimetry, Creatinine CGX
    Calibrator, Multi-Analyte Mixture JIX
    Phosphomolybdate (Colorimetric), Inorganic Phosphorus CEO
    Urease, Photometric, Urea Nitrogen CDN
    Azo Dye, Calcium CJY
    Multi-Analyte Controls, All Kinds (Assayed) JJY
    Colorimetric Method, Gamma-Glutamyl Transpeptidase JPZ
    Biuret (Colorimetric), Total Protein CEK
    Bromcresol Green Dye-Binding, Albumin CIX
    Acid, Uric, Uricase (Colorimetric) KNK
    Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes CGS
    Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase CFJ

    Proprietary Names

    ACE Ferritin Reagent ACE T4 Reagent ACE CEDIA TUP Reagent ACE HbA1c Reagent LDL-C Calibrator ACE LDL-C Reagent LDL Cholesterol Controls LDL-C Controls ACE HDL-C Reagent (plasma) ACE Triglycerides Reagent (plasma) ACE LDL-C Reagent (plasma) ACE Cholesterol Reagent (plasma) ACE Alera Clinical Chemistry System ACE Glucose Reagent ACE Ion Selective Electrode (ISE) Module ACE AST Reagent ACE Amylase Reagent ACE ALT Reagent ACE Alkaline Phosphatase Reagent ACE Total Bilirubin Reagent ACE Carbon Dioxide (CO2-LC) Reagent ACE Magnesium Reagent ACE Direct Bilirubin Reagent ACE Direct Biliubin Reagent ACE Carbon Dioxide Reagent ACE Direct Total Iron-Binding Capacity (TIBC) Reagent ACE Iron Reagent ACE Lipase Reagent ACE Creatinine Reagent (urine) ACE Urine Standard ACE Urea Nitrogen Reagent (urine) ACE Inorganic Phosphorus U.V. Reagent (urine) ACE Calcium-Arsenazo Reagent (urine) ACE HDL-C Reagent (Axcel, plasma) ACE Cholesterol Reagent (Axcel, plasma) ACE LDL-C Reagent (Axcel, plasma) ACE Triglycerides Reagent (Axcel, plasma) Level 1 & Level 2 Controls ACE -GT Reagent ACE Lipase Ragent ACE Albumin Reagent ACE Total Protein Reagent ACE Phosphorus U.V. Reagent ACE Calcium-Arsenazo Reagent ACE CK Reagent ACE BUN/Urea Reagent ACE Creatinine Reagent ACE Uric Acid Reagent ACE Axcel Clinical Chemistry System ACE Total Iron Reagent ACE LDH-L Reagent T4 Calibrators ACE Phosphorus Reagent ACE Triglycerides Reagent ACE Cholesterol Reagent ACE HDL-C Reagent ACE GGT Reagent ACE Bun/Urea Reagent

    Establishment Types

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