BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Progesterone Luminescence Immunoassay

    Reg #: 9710337 · FEI: 3002676602 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    IBL INTERNATIONAL GMBH
    Registration Number
    9710337
    FEI Number
    3002676602
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    FLUGHAFENSTRASSE, 52A
    City
    HAMBURG
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K040923

    Owner / Operator

    Firm Name
    Tecan Group AG
    Operator Number
    9050992
    Address
    103 Seestrasse, --
    City
    Maennedorf
    State
    Zurich
    Postal Code
    8708
    Country
    CH

    US Agent

    Business Name
    Tecan U.S.
    Contact Name
    Taunya Alexander
    Address
    9401 Globe Center Dr Ste 140
    City
    Morrisville
    State
    NC
    ZIP
    27560
    Country
    US
    Email
    [email protected]
    Phone
    919 5725421

    Products

    Device Name Product Code
    Radioimmunoassay, Progesterone JLS

    Proprietary Names

    Progesterone Luminescence Immunoassay SaliCap

    Establishment Types

    Manufacture Medical Device