BEUDAMED
    FDA Registration Active 🇦🇷 Argentina

    WIENER LABORATORIOS S.A.I.C.

    Reg #: 8040374 · FEI: 5864 · Expires 2026
    View on FDA
    Products
    50
    Proprietary Names
    46
    Establishment Types
    1
    Classifications
    50

    Registration Details

    Registration Name
    WIENER LABORATORIOS S.A.I.C.
    Registration Number
    8040374
    FEI Number
    5864
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2571 Maipu
    City
    ROSARIO Santa Fe
    Country
    AR

    Regulatory Submissions

    510(k) Number
    K022962

    Owner / Operator

    Firm Name
    WIENER LABORATORIOS S.A.I.C.
    Operator Number
    8040374
    Address
    RioBamba 2944
    City
    Rosario
    State
    AR-NOTA
    Postal Code
    2000
    Country
    AR

    US Agent

    Business Name
    REGISTRAR CORP
    Contact Name
    David Lennarz
    Address
    144 Research Drive
    City
    HAMPTON
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

    Device Name Product Code
    Diazo Colorimetry, Bilirubin CIG
    Phosphomolybdate (Colorimetric), Inorganic Phosphorus CEO
    Nadh Oxidation/Nad Reduction, Ast/Sgot CIT
    Calibrator, Multi-Analyte Mixture JIX
    Antistreptolysin - Titer/Streptolysin O Reagent GTQ
    Nadh Oxidation/Nad Reduction, Alt/Sgpt CKA
    Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes CGS
    Acid, Uric, Uricase (Colorimetric) KNK
    Glucose Oxidase, Glucose CGA
    U.V. Method, Cpk Isoenzymes JHW
    Colorimetric Method, Triglycerides JGY
    Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes CJE
    Lipase-Esterase, Enzymatic, Photometric, Lipase CHI
    Photometric Method, Iron (Non-Heme) JIY
    Photometric Method, Magnesium JGJ
    2,4-Dinitrophenylhydrazine, Lactate Dehydrogenase CER
    Cresolphthalein Complexone, Calcium CIC
    Urease And Glutamic Dehydrogenase, Urea Nitrogen CDQ
    Catalytic Methods, Amylase JFJ
    Enzyme Linked Immunosorbent Assay, T. Cruzi MIU
    Multi-Analyte Controls, All Kinds (Assayed) JJY
    Colorimetry, Cholinesterase DIH
    Hydrazone Colorimetry, Alt/Sgpt CKD
    Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) JJB
    Nitroprusside, Ketones (Urinary, Non-Quant.) JIN
    Refractometer For Clinical Use JRE
    Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) JMA
    Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) CDM
    Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) JMT
    Dye-Indicator, Ph (Urinary, Non-Quantitative) CEN
    Blood, Occult, Colorimetric, In Urine JIO
    Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) JIR
    Test, Urine Leukocyte LJX
    Method, Enzymatic, Glucose (Urinary, Non-Quantitative) JIL
    Apolipoproteins MSJ
    Lowry (Colorimetric), Total Protein JGP
    Kinetic Method, Gamma-Glutamyl Transpeptidase JQB
    Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase CFJ
    Turbidimetric Method, Lipoproteins JHN
    Enzymatic Esterase--Oxidase, Cholesterol CHH
    Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl LBS
    Enzymatic Method, Creatinine JFY
    Prealbumin, Antigen, Antiserum, Control JZJ
    Azo Dye, Calcium CJY
    Acid, Ferric Ion-Sulfuric, Cholesterol CHD
    Albumin, Antigen, Antiserum, Control DCF
    Olive Oil Emulsion (Turbidimetric), Lipase CET
    Biuret (Colorimetric), Total Protein CEK
    Ferrozine (Colorimetric) Iron Binding Capacity JMO
    Bromcresol Green Dye-Binding, Albumin CIX

    Proprietary Names

    DIAZO COLORIMETRY, BILIRUBIN Fosfatemia UV AA GOT(AST)UV AA Liquida Calibrador A Plus ASO latex Directo Maxi, ASO Latex Turbitest AA NADH OXIDATION/NAD REDUCTION, ALT/SGPT CK-NAC UV AA Liquida, CK-NAC UV AA Uricostat Enzimatico AA Liquida CGA/GLUCOSE OXIDASE, GLUCOSE CK MB DS UV Unitest TG color GPO PAP liquida, TG color GPO PAP AA ALP 405 Cinetica Optimizada, ALP 405 AA Liquida Lipase AA Liquida Fer-color AA Mg-color AA 2,4-DINITROPHENYLHYDRAZINE, LACTATE DEHYDROGENASE Ca-Color AA Urea UV cinetica AA, Urea UV cinetica AA liquida CATALYTIC METHODS, AMYLASE Chagatest ELISA Recombinante v.3 Standatrol SE 2 Niveles Colinesterasa AA GPT (ALT) UV AA liquida, GPT (ALT) UV AA, GPT (ALT) UV Unitest Urine Strip APOLIPOPROTEINS Proti 2 reactivo EDTA-Cu Gamma G-Test Cinetica AA G-Test cinetica AA liquida LDH-L Apo A-I Turbitest AA, Apo B Turbitest AA Colestat Enzimatico AA, Colestat Enzimatico, Colestat Enzimatico AA Liquida GOT(AST)UV AA, GOT(AST)UV Unitest HDL Colesterol Monofase AA HDL Colesterol monofase AA v.2 Amilasa 405 Cinetica AA, Amilasa 405 Cinetica Unitest, Amilasa 405 AA Liquida Creatinina Cinetica AA Prealbumin Turbitest AA Ca-Color Arsenazo III AA Bilirrubina Directa AA, Bilirrubina Total AA ACID, FERRIC ION-SULFURIC, CHOLESTEROL Albumin Turbitest AA OLIVE OIL EMULSION (TURBIDIMETRIC), LIPASE Proti U/LCR Fer-color Transferrina Albumina AA Uricostat Enzimatico AA

    Establishment Types

    Manufacture Medical Device