Tecan Group Ag

FDA Filings

This page includes the latest FDA filings for Tecan Group Ag. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3003559191
FEI Number3003559191
NameTecan Trading AG
Owner & OperatorTecan Group AG
Contact Address103 Seestrasse --
Maennedorf CH-ZH Zurich 8708 CH
Official Correspondent
  • Claudia Solimeo Meneghisse
  • 41-044-922-8992
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address103 Seestrasse
Maennedorf Zurich, 8708 CH
Establishment TypeComplaint File Establishment per 21 CFR 820.198

Registration Number9710337
FEI Number3002676602
NameIBL INTERNATIONAL GMBH
Owner & OperatorTecan Group AG
Contact Address103 Seestrasse --
Maennedorf CH-ZH Zurich 8708 CH
Official Correspondent
  • Claudia Solimeo Meneghisse
  • 41-044-922-8992
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressFLUGHAFENSTRASSE, 52A
HAMBURG Hamburg, D-22335 DE
Establishment Type
  • Manufacture Medical Device
  • Repack or Relabel Medical Device

Registration Number2916719
FEI Number2916719
NameTECAN SYSTEMS INC
Owner & OperatorTecan Group AG
Contact Address103 Seestrasse --
Maennedorf CH-ZH Zurich 8708 CH
Official Correspondent
  • Claudia Solimeo Meneghisse
  • 41-044-922-8992
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2450 Zanker Rd
SAN JOSE, CA 95131 US
Establishment TypeManufacture Medical Device for Another Party (Contract Manufacturer)

Registration Number3010848378
FEI Number3010848378
NameTECAN Trading AG-Central Warehouse Americas
Owner & OperatorTecan Group AG
Contact Address103 Seestrasse --
Maennedorf CH-ZH Zurich 8708 CH
Official Correspondent
  • Claudia Solimeo Meneghisse
  • 41-044-922-8992
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration AddressCrane Worldwide Logistics 10240 Western Ridge Road, Suite L
Charlotte, NC 28273 US

Registration Number3003402518
FEI Number3003402518
NameLaura Nea
Owner & OperatorTecan Group AG
Contact Address103 Seestrasse --
Maennedorf CH-ZH Zurich 8708 CH
Official Correspondent
  • Claudia Solimeo Meneghisse
  • 41-044-922-8992
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address9401 Globe Center Drive Suite No. 140
Morrisville, NC 27560 US
Establishment Type
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Develop Specifications But Do Not Manufacture At This Facility

Registration Number1037985
FEI Number1037985
NameTECAN U.S.
Owner & OperatorTecan Group AG
Contact Address103 Seestrasse --
Maennedorf CH-ZH Zurich 8708 CH
Official Correspondent
  • Claudia Solimeo Meneghisse
  • 41-044-922-8992
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address9401 Globe Center Dr Ste 140
Morrisville, NC 27560 US

Registration Number3010160459
FEI Number3010160459
NameTecan Software Competence Center GmbH
Owner & OperatorTecan Group AG
Contact Address103 Seestrasse --
Maennedorf CH-ZH Zurich 8708 CH
Official Correspondent
  • Claudia Solimeo Meneghisse
  • 41-044-922-8992
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressPeter-Sander-Strasse 41a
Mainz-Kastel Rheinland-Pfalz, 55252 DE
Establishment TypeDevelop Specifications But Do Not Manufacture At This Facility

Registration Number3002710220
FEI Number3002710220
NameTECAN AUSTRIA GMBH
Owner & OperatorTecan Group AG
Contact Address103 Seestrasse --
Maennedorf CH-ZH Zurich 8708 CH
Official Correspondent
  • Claudia Solimeo Meneghisse
  • 41-044-922-8992
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address1A UNTERSBERGSTRASSE
GROEDIG Salzburg, 5082 AT
Establishment Type
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device
Company
DeviceDate
Tecan Trading AG [Tecan Group AG]
Cortisol Saliva Luminescence Immunoassay2016-11-01
IBL INTERNATIONAL GMBH [Tecan Group AG]
Cortisol Saliva Luminescence Immunoassay2016-11-01
Tecan Trading AG [Tecan Group AG]
Active-B12 (Holotranscobalamin) ELISA2016-11-01
IBL INTERNATIONAL GMBH [Tecan Group AG]
Active-B12 (Holotranscobalamin) ELISA2016-11-01
Tecan Trading AG [Tecan Group AG]
Acetylcholine Receptor Autoantibodies (ARAb) RRA2016-11-01
IBL INTERNATIONAL GMBH [Tecan Group AG]
Acetylcholine Receptor Autoantibodies (ARAb) RRA2016-11-01
Tecan Trading AG [Tecan Group AG]
SaliCap2016-11-01
Tecan Trading AG [Tecan Group AG]
Progesterone Luminescence Immunoassay2016-11-01
IBL INTERNATIONAL GMBH [Tecan Group AG]
SaliCap2016-11-01
IBL INTERNATIONAL GMBH [Tecan Group AG]
Progesterone Luminescence Immunoassay2016-11-01
Tecan Trading AG [Tecan Group AG]
Unassayed Testosterone QC Material2016-11-01
Tecan Trading AG [Tecan Group AG]
Testosterone Luminescence Immunoassay2016-11-01
IBL INTERNATIONAL GMBH [Tecan Group AG]
Unassayed Testosterone QC Material2016-11-01
IBL INTERNATIONAL GMBH [Tecan Group AG]
Testosterone Luminescence Immunoassay2016-11-01
Tecan Trading AG [Tecan Group AG]
Unassayed Testosterone QC Material2016-11-01
Tecan Trading AG [Tecan Group AG]
Testosterone Luminescence Immunoassay2016-11-01
IBL INTERNATIONAL GMBH [Tecan Group AG]
Unassayed Testosterone QC Material2016-11-01
IBL INTERNATIONAL GMBH [Tecan Group AG]
Testosterone Luminescence Immunoassay2016-11-01
Tecan Trading AG [Tecan Group AG]
Unassayed Testosterone QC Material2016-11-01
Tecan Trading AG [Tecan Group AG]
Testosterone Luminescence Immunoassay2016-11-01
IBL INTERNATIONAL GMBH [Tecan Group AG]
Unassayed Testosterone QC Material2016-11-01
IBL INTERNATIONAL GMBH [Tecan Group AG]
Testosterone Luminescence Immunoassay2016-11-01
Tecan Trading AG [Tecan Group AG]
DHEA-S ELISA2016-11-01
IBL INTERNATIONAL GMBH [Tecan Group AG]
DHEA-S ELISA2016-11-01
Tecan Trading AG [Tecan Group AG]
17beta-Estradiol Saliva Luminescence Immunoassay2016-11-01
IBL INTERNATIONAL GMBH [Tecan Group AG]
17beta-Estradiol Saliva Luminescence Immunoassay2016-11-01
Tecan Trading AG [Tecan Group AG]
AUTOREADER IV2012-12-05
TECAN AUSTRIA GMBH [Tecan Group AG]
AUTOREADER IV2012-12-05
Tecan Trading AG [Tecan Group AG]
Freedom EVOlyzer2008-01-17
Laura Nea [Tecan Group AG]
Freedom EVOlyzer2008-01-17
Tecan Trading AG [Tecan Group AG]
SUNRISE2007-12-21
Tecan Trading AG [Tecan Group AG]
SUNRISE-RC/TW EVOLYZER2007-12-21
Tecan Trading AG [Tecan Group AG]
SUNRISE-RC/ST TC CRE2007-12-21
Tecan Trading AG [Tecan Group AG]
SUNRISE-RC/ST RMP2007-12-21
Tecan Trading AG [Tecan Group AG]
SUNRISE-RC/ST ML2007-12-21
Tecan Trading AG [Tecan Group AG]
SUNRISE-RC/ST GL.ABBOTT2007-12-21
Tecan Trading AG [Tecan Group AG]
SUNRISE-RC/ST GENALYSER2007-12-21
Tecan Trading AG [Tecan Group AG]
SUNRISE-RC/ST EVOLYZER2007-12-21
Tecan Trading AG [Tecan Group AG]
SUNRISE-RC/6F EVOLYZER2007-12-21
Tecan Trading AG [Tecan Group AG]
SUNRISE-RC/6F ENFER2007-12-21
Tecan Trading AG [Tecan Group AG]
SUNRISE BF2007-12-21
Tecan Trading AG [Tecan Group AG]
SUNRISE BF V22007-12-21
Tecan Trading AG [Tecan Group AG]
PR41002007-12-21
Tecan Trading AG [Tecan Group AG]
PR31002007-12-21
Tecan Trading AG [Tecan Group AG]
INFINITE M10002007-12-21
Tecan Trading AG [Tecan Group AG]
INFINITE M1000 PRO2007-12-21
Tecan Trading AG [Tecan Group AG]
INFINITE F502007-12-21
Tecan Trading AG [Tecan Group AG]
INFINITE F5002007-12-21
Tecan Trading AG [Tecan Group AG]
INFINITE F50 ROBOTIC2007-12-21
Tecan Trading AG [Tecan Group AG]
INFINITE F50 ROBOTIC FS2007-12-21
Tecan Trading AG [Tecan Group AG]
INFINITE 2002007-12-21
Tecan Trading AG [Tecan Group AG]
INFINITE 200 PRO2007-12-21
Tecan Trading AG [Tecan Group AG]
INFINITE 200 PRO - INFINITE M Plex2007-12-21
Tecan Trading AG [Tecan Group AG]
INFINITE 200 PRO - INFINITE M Nano2007-12-21
Tecan Trading AG [Tecan Group AG]
INFINITE 200 PRO - INFINITE M Nano+2007-12-21
Tecan Trading AG [Tecan Group AG]
INFINITE 200 PRO - INFINITE Lumi2007-12-21
Tecan Trading AG [Tecan Group AG]
INFINITE 200 PRO - INFINITE F Plex2007-12-21
Tecan Trading AG [Tecan Group AG]
INFINITE 200 PRO - INFINITE F Nano+2007-12-21
TECAN AUSTRIA GMBH [Tecan Group AG]
SUNRISE2007-12-21
TECAN AUSTRIA GMBH [Tecan Group AG]
SUNRISE-RC/TW EVOLYZER2007-12-21
TECAN AUSTRIA GMBH [Tecan Group AG]
SUNRISE-RC/ST TC CRE2007-12-21
TECAN AUSTRIA GMBH [Tecan Group AG]
SUNRISE-RC/ST RMP2007-12-21
TECAN AUSTRIA GMBH [Tecan Group AG]
SUNRISE-RC/ST ML2007-12-21
TECAN AUSTRIA GMBH [Tecan Group AG]
SUNRISE-RC/ST GL.ABBOTT2007-12-21
TECAN AUSTRIA GMBH [Tecan Group AG]
SUNRISE-RC/ST GENALYSER2007-12-21
TECAN AUSTRIA GMBH [Tecan Group AG]
SUNRISE-RC/ST EVOLYZER2007-12-21
TECAN AUSTRIA GMBH [Tecan Group AG]
SUNRISE-RC/6F EVOLYZER2007-12-21
TECAN AUSTRIA GMBH [Tecan Group AG]
SUNRISE-RC/6F ENFER2007-12-21
TECAN AUSTRIA GMBH [Tecan Group AG]
SUNRISE BF2007-12-21
TECAN AUSTRIA GMBH [Tecan Group AG]
SUNRISE BF V22007-12-21
TECAN AUSTRIA GMBH [Tecan Group AG]
PR41002007-12-21
TECAN AUSTRIA GMBH [Tecan Group AG]
PR31002007-12-21
TECAN AUSTRIA GMBH [Tecan Group AG]
INFINITE M10002007-12-21
TECAN AUSTRIA GMBH [Tecan Group AG]
INFINITE M1000 PRO2007-12-21
TECAN AUSTRIA GMBH [Tecan Group AG]
INFINITE F502007-12-21
TECAN AUSTRIA GMBH [Tecan Group AG]
INFINITE F5002007-12-21
TECAN AUSTRIA GMBH [Tecan Group AG]
INFINITE F50 ROBOTIC2007-12-21
TECAN AUSTRIA GMBH [Tecan Group AG]
INFINITE F50 ROBOTIC FS2007-12-21
TECAN AUSTRIA GMBH [Tecan Group AG]
INFINITE 2002007-12-21
TECAN AUSTRIA GMBH [Tecan Group AG]
INFINITE 200 PRO2007-12-21
TECAN AUSTRIA GMBH [Tecan Group AG]
INFINITE 200 PRO - INFINITE M Plex2007-12-21
TECAN AUSTRIA GMBH [Tecan Group AG]
INFINITE 200 PRO - INFINITE M Nano2007-12-21
TECAN AUSTRIA GMBH [Tecan Group AG]
INFINITE 200 PRO - INFINITE M Nano+2007-12-21
TECAN AUSTRIA GMBH [Tecan Group AG]
INFINITE 200 PRO - INFINITE Lumi2007-12-21
TECAN AUSTRIA GMBH [Tecan Group AG]
INFINITE 200 PRO - INFINITE F Plex2007-12-21
TECAN AUSTRIA GMBH [Tecan Group AG]
INFINITE 200 PRO - INFINITE F Nano+2007-12-21
Tecan Trading AG [Tecan Group AG]
PW3842005-02-23
Tecan Trading AG [Tecan Group AG]
HYDROSPEED2005-02-23
Tecan Trading AG [Tecan Group AG]
HYDROFLEX2005-02-23
Tecan Trading AG [Tecan Group AG]
HYDROFLEX FREEDOM EVO2005-02-23
Tecan Trading AG [Tecan Group AG]
HYDROFLEX EVOLYZER 8CH2005-02-23
Tecan Trading AG [Tecan Group AG]
HYDROFLEX EVOLYZER 16CH2005-02-23
Tecan Trading AG [Tecan Group AG]
HYDROFLEX ELISA2005-02-23
Tecan Trading AG [Tecan Group AG]
COLUMBUS2005-02-23
Tecan Trading AG [Tecan Group AG]
96PW2005-02-23
TECAN AUSTRIA GMBH [Tecan Group AG]
PW3842005-02-23
TECAN AUSTRIA GMBH [Tecan Group AG]
HYDROSPEED2005-02-23
TECAN AUSTRIA GMBH [Tecan Group AG]
HYDROFLEX2005-02-23
TECAN AUSTRIA GMBH [Tecan Group AG]
HYDROFLEX FREEDOM EVO2005-02-23
TECAN AUSTRIA GMBH [Tecan Group AG]
HYDROFLEX EVOLYZER 8CH2005-02-23
TECAN AUSTRIA GMBH [Tecan Group AG]
HYDROFLEX EVOLYZER 16CH2005-02-23
TECAN AUSTRIA GMBH [Tecan Group AG]
HYDROFLEX ELISA2005-02-23
TECAN AUSTRIA GMBH [Tecan Group AG]
COLUMBUS2005-02-23
TECAN AUSTRIA GMBH [Tecan Group AG]
96PW2005-02-23
Tecan Trading AG [Tecan Group AG]
PROFI BLOT T482005-02-23
Tecan Trading AG [Tecan Group AG]
PROFI BLOT 482005-02-23
Tecan Trading AG [Tecan Group AG]
PROFI BLOT 48-2in12005-02-23
TECAN AUSTRIA GMBH [Tecan Group AG]
PROFI BLOT T482005-02-23
TECAN AUSTRIA GMBH [Tecan Group AG]
PROFI BLOT 482005-02-23
TECAN AUSTRIA GMBH [Tecan Group AG]
PROFI BLOT 48-2in12005-02-23
Laura Nea [Tecan Group AG]
PROFI BLOT T482005-02-23
Laura Nea [Tecan Group AG]
PROFI BLOT 482005-02-23
Laura Nea [Tecan Group AG]
PROFI BLOT 48-2in12005-02-23
Tecan Trading AG [Tecan Group AG]
Magellan Tracker2005-02-23
Tecan Trading AG [Tecan Group AG]
Magellan Standard2005-02-23
Tecan Trading AG [Tecan Group AG]
Magellan Pro2005-02-23
Tecan Trading AG [Tecan Group AG]
Magellan Basic2005-02-23
TECAN AUSTRIA GMBH [Tecan Group AG]
Magellan Tracker2005-02-23
TECAN AUSTRIA GMBH [Tecan Group AG]
Magellan Standard2005-02-23
TECAN AUSTRIA GMBH [Tecan Group AG]
Magellan Pro2005-02-23
TECAN AUSTRIA GMBH [Tecan Group AG]
Magellan Basic2005-02-23
Tecan Trading AG [Tecan Group AG]
Freedom EVOlyzer2005-02-22
Laura Nea [Tecan Group AG]
Freedom EVOlyzer2005-02-22
Tecan Trading AG [Tecan Group AG]
INFINITE M10002002-04-30
Tecan Trading AG [Tecan Group AG]
INFINITE M1000 PRO2002-04-30
Tecan Trading AG [Tecan Group AG]
INFINITE F5002002-04-30
Tecan Trading AG [Tecan Group AG]
INFINITE F200 MICROPLATE FLUORESCENCE READER2002-04-30
Tecan Trading AG [Tecan Group AG]
INFINITE 2002002-04-30
Tecan Trading AG [Tecan Group AG]
INFINITE 200 PRO2002-04-30
Tecan Trading AG [Tecan Group AG]
INFINITE 200 PRO - INFINITE M Plex2002-04-30
Tecan Trading AG [Tecan Group AG]
INFINITE 200 PRO - INFINITE M Nano2002-04-30
Tecan Trading AG [Tecan Group AG]
INFINITE 200 PRO - INFINITE M Nano+2002-04-30
Tecan Trading AG [Tecan Group AG]
INFINITE 200 PRO - INFINITE Lumi2002-04-30
Tecan Trading AG [Tecan Group AG]
INFINITE 200 PRO - INFINITE F Plex2002-04-30
Tecan Trading AG [Tecan Group AG]
INFINITE 200 PRO - INFINITE F Nano+2002-04-30
TECAN AUSTRIA GMBH [Tecan Group AG]
INFINITE M10002002-04-30
TECAN AUSTRIA GMBH [Tecan Group AG]
INFINITE M1000 PRO2002-04-30
TECAN AUSTRIA GMBH [Tecan Group AG]
INFINITE F5002002-04-30
TECAN AUSTRIA GMBH [Tecan Group AG]
INFINITE F200 MICROPLATE FLUORESCENCE READER2002-04-30
TECAN AUSTRIA GMBH [Tecan Group AG]
INFINITE 2002002-04-30
TECAN AUSTRIA GMBH [Tecan Group AG]
INFINITE 200 PRO2002-04-30
TECAN AUSTRIA GMBH [Tecan Group AG]
INFINITE 200 PRO - INFINITE M Plex2002-04-30
TECAN AUSTRIA GMBH [Tecan Group AG]
INFINITE 200 PRO - INFINITE M Nano2002-04-30
TECAN AUSTRIA GMBH [Tecan Group AG]
INFINITE 200 PRO - INFINITE M Nano+2002-04-30
TECAN AUSTRIA GMBH [Tecan Group AG]
INFINITE 200 PRO - INFINITE Lumi2002-04-30
TECAN AUSTRIA GMBH [Tecan Group AG]
INFINITE 200 PRO - INFINITE F Plex2002-04-30
TECAN AUSTRIA GMBH [Tecan Group AG]
INFINITE 200 PRO - INFINITE F Nano+2002-04-30
Tecan Trading AG [Tecan Group AG]
Genesis FE 500 :2001-11-06
Tecan Trading AG [Tecan Group AG]
Freedom EVOlyzer :2001-11-06
Tecan Trading AG [Tecan Group AG]
Freedom EVO Clinical :2001-11-06
Tecan Trading AG [Tecan Group AG]
Freedom EVO :2001-11-06
Tecan Trading AG [Tecan Group AG]
Freedom EVO 75 :2001-11-06
Tecan Trading AG [Tecan Group AG]
Fluent2001-11-06
Tecan Software Competence Center GmbH [Tecan Group AG]
Genesis FE 500 :2001-11-06
Tecan Software Competence Center GmbH [Tecan Group AG]
Freedom EVOlyzer :2001-11-06
Tecan Software Competence Center GmbH [Tecan Group AG]
Freedom EVO Clinical :2001-11-06
Tecan Software Competence Center GmbH [Tecan Group AG]
Freedom EVO :2001-11-06
Tecan Software Competence Center GmbH [Tecan Group AG]
Freedom EVO 75 :2001-11-06
Tecan Software Competence Center GmbH [Tecan Group AG]
Fluent2001-11-06
Laura Nea [Tecan Group AG]
Genesis FE 500 :2001-11-06
Laura Nea [Tecan Group AG]
Freedom EVOlyzer :2001-11-06
Laura Nea [Tecan Group AG]
Freedom EVO Clinical :2001-11-06
Laura Nea [Tecan Group AG]
Freedom EVO :2001-11-06
Laura Nea [Tecan Group AG]
Freedom EVO 75 :2001-11-06
Laura Nea [Tecan Group AG]
Fluent2001-11-06

Related Finance Registrations
NCAGE CodeST076TECAN GROUP AG
CAGE CodeST076TECAN GROUP AG
SEC0001548253Tecan Group AG/ADR
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