Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003559191

FEI Number

3003559191

Entity Name

Tecan Trading AG

City/State/Country

Maennedorf Zurich, CH

Establishment Address

103 Seestrasse, Maennedorf Zurich 8708, CH

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Tecan Group AG (Owner Number: 9050992)

Owner / Operator Contact Address

103 Seestrasse, --, Maennedorf, CH-ZH 8708, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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 F500 INFINITE M1000 INFINITE 200 PRO - INFINITE F Plex INFINITE 200 PRO - INFINITE Lumi INFINITE 200 PRO - INFINITE M Nano INFINITE 200 PRO - INFINITE M Nano+ INFINITE 200 PRO - INFINITE M Plex INFINITE 200 PRO - INFINITE F Nano+ INFINITE M1000 PRO INFINITE 200 PRO INFINITE 200 INFINITE F200 MICROPLATE FLUORESCENCE READER DHEA-S ELISA DHEA ELISA

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JLS	Radioimmunoassay, Progesterone	Clinical Chemistry	Class 1	862.1620	2016-11-01
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2005-02-23
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2005-02-22
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2023-09-12
JJQ	Colorimeter, Photometer, Spectrophotometer For Clinical Use	Clinical Chemistry	Class 1	862.2300	2007-12-21
JLX	Radioimmunoassay, 17-Hydroxyprogesterone	Clinical Chemistry	Class 1	862.1395	2016-11-01
NST	Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-Blocking	Immunology	Class 2	866.5660	2016-11-01
NHG	Enzyme Immunoassay, Cortisol, Salivary	Clinical Chemistry	Class 2	862.1205	2016-11-01
KHO	Fluorometer, For Clinical Use	Clinical Chemistry	Class 1	862.2560	2002-04-30
JKC	Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)	Clinical Chemistry	Class 1	862.1245	2016-11-01
OTV	Research Use Only/Clinical Chemistry Devices	Unknown	Class N	N/A	2017-12-15

Official Correspondent

No official correspondent registered.

US Agent Details

Taunya Alexander Business: Tecan U.S. Email: regulatory.affairs.us@tecan.net Phone: (919) 5725421

Related Public Records

Same Entity

Tecan Group AG

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3010160459	Tecan Software Competence Center GmbH	Mainz-Kastel Rhineland-Palatinate, DE
3003402518	TECAN SCHWEIZ AG	MAENNEDORF ZUERICH Zurich, CH
9710337	IBL INTERNATIONAL GMBH	HAMBURG, DE
3002710220	TECAN AUSTRIA GMBH	GROEDIG Salzburg, AT
3003537036	TECAN CDMO SOLUTIONS MH, CORP.	MORGAN HILL, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K872302	Ciba Corning Diagnostics Corp.	MODEL 550 EXPRESS CLINICAL CHEMISTRY ANALYZER	1987-09-08
K760232	Instrumentation Laboratory CO	PRINTER, IL 460	1976-08-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2008	Beckman Coulter Inc	1	FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013	Biomerieux Inc	1	PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.
Z-0008-06	Abbott Laboratories, Inc	1	ARCHITECT c800 for Conventional Units and for SI Units, Version 5.00.
Z-0008-2024	Ortho-Clinical Diagnostics, Inc.	1	Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry System (Product Code 6801375), VITROS 5,1 Chemistry System (Refurbished) (Product Code 6801890), VITROS 3600 Immunodiagnostic System (Product Code 6802783), VITROS 3600 Immunodiagnostic System (Refurbished) (Product Code 6802914), VITROS 4600 Chemistry System (Product Code 6802445), VITROS 4600 Chemistry System (Refurbished) (Product Code 6900440), VITROS 5600 Integrated System (Product Code 6802413), VITROS 5600 Integrated System (Refurbished) (Product Code 6802915), VITROS XT 3400 Chemistry System (Product Code 6844458), and VITROS XT 7600 Integrated System (Product Code 6844461)
Z-0009-06	Beckman Coulter Inc	1	Synchron LX Systems Version 4.5 Operating Software

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003559191. Last updated year: 2026. Please use registration number 3003559191 when referencing this establishment in official correspondence.