BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CENOGENICS CORP.

    Reg #: 2250030 · FEI: 2250030 · Expires 2026
    View on FDA
    Products
    15
    Proprietary Names
    22
    Establishment Types
    3
    Classifications
    15

    Registration Details

    Registration Name
    CENOGENICS CORP.
    Registration Number
    2250030
    FEI Number
    2250030
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    100 RT. 520, Drawer 308
    City
    MORGANVILLE
    State
    NJ
    ZIP
    07751
    Country
    US

    Regulatory Submissions

    510(k) Number
    K894793

    Owner / Operator

    Firm Name
    CENOGENICS CORPORATION
    Operator Number
    2243923
    Address
    100 RT. 520
    City
    Morganville
    State
    NJ
    Postal Code
    07751
    Country
    US
    Correspondent
    NITZA KATZ

    Products

    Device Name Product Code
    Antigens (Febrile), Agglutination, Brucella Spp. GSO
    Antigens, Febrile (Weil-Felix), All Groups GSZ
    System, Test, Infectious Mononucleosis KTN
    Antigens, Nontreponemal, All GMQ
    Streptolysin O IBA
    Antiserum, Positive And Negative Febrile Antigen Control Serum GSN
    Visual, Pregnancy Hcg, Prescription Use JHI
    Method, Enzymatic, Glucose (Urinary, Non-Quantitative) JIL
    Reagent, Occult Blood KHE
    Antistreptolysin - Titer/Streptolysin O Reagent GTQ
    System, Test, Rheumatoid Factor DHR
    Kit, Test, Pregnancy, Hcg, Over The Counter LCX
    System, Test, C-Reactive Protein DCN
    Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. GNC
    Antisera, Control For Nontreponemal Tests GMP

    Proprietary Names

    ROSE BENGAL ANTIGEN BRUCELLA ABORTUS AND BRUCELLA MELITENSIS ANTIGENS BRUCELLA ABORTUS AND BRU PROTEUS "_" (SOMATIC ANTIGEN) MONODEX VDRL ANTIGEN TEST KIT ACCULYSIN-O FEBRILE POSITIVE CONTROL A ACCUNATE ONE-STEP CASSETTE ACCUNATE-CHOICE CHEMVIEW-10 PROFESSIONAL SINGLE SLIDE TEST DENCOCCULT TRI-SLIDE STOOL BLOOD TEST ANTI-STREPTOLYSIN CONTROL SERUM RF Latex Test Set Rheumatex ACCUNATE HOME PREGNANCY TEST Immunex CRP Latex Test Kit SALMONELLA GROUP "_" ANTIGENS VDRL CONTROL SERUM

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)