BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    Tecan Trading AG

    Reg #: 3003559191 · FEI: 3003559191 · Expires 2026
    View on FDA
    Products
    22
    Proprietary Names
    90
    Establishment Types
    1
    Classifications
    22

    Registration Details

    Registration Name
    Tecan Trading AG
    Registration Number
    3003559191
    FEI Number
    3003559191
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    103 Seestrasse
    City
    Maennedorf Zurich
    Country
    CH

    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
    Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use LXG
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    General Purpose Reagent PPM
    Colorimeter, Photometer, Spectrophotometer For Clinical Use JJQ
    Radioimmunoassay, 17-Hydroxyprogesterone JLX
    Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-Blocking NST
    Enzyme Immunoassay, Cortisol, Salivary NHG
    Fluorometer, For Clinical Use KHO
    Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) JKC
    Research Use Only/Clinical Chemistry Devices OTV
    Calculator/Data Processing Module, For Clinical Use JQP
    Research Use Only/Immunology Devices OTR
    Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use JQC
    Test, Equipment, Automated Bloodborne Pathogen MZA
    Analyzer, Chemistry, Micro, For Clinical Use JJF
    Station, Pipetting And Diluting, For Clinical Use JQW
    Radioimmunoassay, Estradiol CHP
    Calibrator, Secondary JIT
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Radioimmunoassay, Testosterones And Dihydrotestosterone CDZ
    Slide Stainer, Automated KPA

    Proprietary Names

    Progesterone Luminescence Immunoassay SaliCap HYDROFLEX PLUS HYDROFLEX HYDROFLEX EVOLYZER 8CH HYDROFLEX EVOLYZER 16CH HYDROFLEX ELISA HYDROSPEED HYDROFLEX FREEDOM EVO 96PW PW384 COLUMBUS Freedom EVOlyzer Steroid Tuning Mix 4 Steroid Tuning Mix 1 Steroid Tuning Mix 2 Steroid Tuning Mix 3 INFINITE 200 PRO - INFINITE F Nano+ INFINITE 200 PRO - INFINITE Lumi INFINITE 200 PRO - INFINITE M Nano INFINITE 200 PRO - INFINITE M Plex INFINITE 200 PRO - INFINITE F Plex INFINITE 200 PRO - INFINITE M Nano+ INFINITE F50 PLUS INFINITE M1000 INFINITE F500 INFINITE 200 INFINITE F50 ROBOTIC INFINITE F50 SUNRISE INFINITE M1000 PRO SUNRISE-RC/6F ENFER SUNRISE-RC/ST TC CRE SUNRISE-RC/TW EVOLYZER SUNRISE-RC/ST GL.ABBOTT INFINITE F50 ROBOTIC FS SUNRISE-RC/6F EVOLYZER SUNRISE-RC/ST RMP INFINITE 200 PRO SUNRISE-RC/ST EVOLYZER SUNRISE BF SUNRISE-RC/ST GENALYSER SUNRISE-RC/ST ML PR4100 SUNRISE BF V2 17-OH-Progesterone ELISA (30223011) Acetylcholine Receptor Autoantibodies (ARAb) RRA Cortisol Saliva Luminescence Immunoassay INFINITE F200 MICROPLATE FLUORESCENCE READER DHEA-S ELISA DHEA ELISA Magellan Pro Magellan Basic Magellan Pro Standard Magellan Pro Tracker Magellan Tracker Magellan Standard Anti-Muellerian Hormone (AMH) ELISA DEPROTEINIZATION INT.STD.SOL.LC-MS VITAE CA 72-4 ELISA CALIBRATOR SET IMMUNOSUPPRESANTS RUO CONTROL SET LC-MS PSYCHOT.MED. 2 RUO INTERNAL STD. D3 LC-MS VB1B6 10X6ML RUO CONTROL SET LC-MS PSYCHOT.MED. 1 RUO Human IL-6 ELISA Spermatozoa-Ab ELISA WASH BUFFER ELISA KITS 30ML 1VIAL CALIBRATOR SET LC-MS PSYCHOT.MED. 1 RUO CALIBRATOR SET LC-MS PSYCHOT.MED. 2 RUO Cardiolipin IgM ELISA Tec-Trace Metanephrines Control set ELISA PROINSULIN INTACT AUTOREADER IV Freedom EVO 75 : Freedom EVO : Freedom EVOlyzer : Genesis FE 500 : Freedom EVO Clinical : Fluent AVENIO Edge System AcfS Detection Robot AcfS Library Robot Veya Dx AcfS L&D Equipment Installation Bundle 17beta-Estradiol Saliva Luminescence Immunoassay Testosterone Luminescence Immunoassay Unassayed Testosterone QC Material PROFI BLOT 48-2in1 PROFI BLOT T48 PROFI BLOT 48

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198