BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    Prostate Specific Membrane Antigen

    Reg #: 3004859032 · FEI: 3004859032 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    46
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    LEICA BIOSYSTEMS NEWCASTLE LTD
    Registration Number
    3004859032
    FEI Number
    3004859032
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    BALLIOL BUSINESS PARK WEST, BENTON LANE
    City
    NEWCASTLE UPON TYNE
    Country
    GB

    Owner / Operator

    Firm Name
    Leica Biosystems, division of Leica Microsystems, Inc.
    Operator Number
    10054155
    Address
    21440 W. Lake Cook Road, Floor 5
    City
    Deer Park
    State
    IL
    Postal Code
    60010
    Country
    US
    Correspondent
    Adam Blunier

    US Agent

    Business Name
    Leica Biosystems, division of Leica Microsystems, Inc.
    Contact Name
    Adam Blunier
    Address
    21440 W. Lake Cook Road, Floor 5
    City
    Deer Park
    State
    IL
    ZIP
    60010
    Country
    US
    Email
    [email protected]
    Phone
    630 6340069 ext. 3462

    Products

    Device Name Product Code
    Reagents, Specific, Analyte MVU

    Proprietary Names

    Prostate Specific Membrane Antigen ACD RNA ISH Probe PPIB (Positive Control) ACD RNA ISH Probe DapB (Negative Control) ACD RNA ISH Probe Albumin Pax-5 Cytokeratin 8 7mL NCL RTU Lambda Probe-ASR Aurora Kinase 2 7mL NCL RTU Kappa Probe-ASR CD25 (Interleukin 2 Receptor) 7mL NCL RTU CMV Probe-ASR ACD RNA ISH Probe HPV-6 (RS7757) ACD RNA ISH Probe (concentrate) HPV-11 (RS7860) 7mL NCL RTU RNAPosContProbe-ASR 7mL NCL RTU RNANegContProbe-ASR Villin ACD RNA ISH Probe CMV ACD RNA ISH Probe EBV ACD RNA ISH Probe ACD RNA ISH Probe TTF1 (Thyroid Transcription Factor-1) Vascular endothelial Growth Factor Receptor 3 Helicobacter pylori 7mL NCL RTU EBER Probe-ASR Helicobacter pylori (liquid primary antibody) ACD RNA ISH Probe (concentrate) HPV-33 (RS7863) B Cell Specific Octamer Bind Protein-1 (BOB-1) ACD RNA ISH Probe HPV-31 (RS7759) ACD RNA ISH Probe (concentrate) HPV-18 (RS7861) ACD RNA ISH Probe (concentrate) HPV-31 (RS7862) ACD RNA ISH Probe HPV-16 (RS7758) ACD RNA ISH Probe Napsin A ACD RNA ISH Probe UBC (Pos. Ctrl.) Beta-Dystroglycan Merosin Laminin Alpha 2 Chain Beta-Sarcoglycan (liquid primary antibody) Spectrin (recommended for human use) Dystrophin (C-terminus) Alpha-Sarcoglycan (Adhalin) (liquid primary antibody) Dystrophin (Rod Domain) Sarcoglycan - Delta Emerin Dysferlin Dysferlin 2 Sarcoglycan - Gamma Utrophin (N-terminus) Dystrophin (N-terminus)

    Establishment Types

    Manufacture Medical Device