Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9710337

FEI Number

3002676602

Entity Name

IBL INTERNATIONAL GMBH

City/State/Country

HAMBURG, DE

Establishment Address

FLUGHAFENSTRASSE, 52A, HAMBURG 22335, DE

Establishment Type(s)

Manufacture Medical Device

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

K033786

PMA Number

N/A

All Registered Proprietary Names

Progesterone Luminescence Immunoassay SaliCap 17beta-Estradiol Saliva Luminescence Immunoassay Cortisol Saliva Luminescence Immunoassay 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 Testosterone Luminescence Immunoassay Unassayed Testosterone QC Material

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
CHP	Radioimmunoassay, Estradiol	Clinical Chemistry	Class 1	862.1260	2016-11-01
NHG	Enzyme Immunoassay, Cortisol, Salivary	Clinical Chemistry	Class 2	862.1205	2016-11-01
OTR	Research Use Only/Immunology Devices	Unknown	Class N	N/A	2016-11-15
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2016-11-01
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2016-11-01
CDZ	Radioimmunoassay, Testosterones And Dihydrotestosterone	Clinical Chemistry	Class 1	862.1680	2016-11-01

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
3003559191	Tecan Trading AG	Maennedorf Zurich, CH
3003402518	TECAN SCHWEIZ AG	MAENNEDORF ZUERICH Zurich, CH
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
K882259	Diagnostic Chemicals, Ltd. (Usa)	DC-BILITROL CATALOGUE # SE-021, SE-022, SE-023	1988-07-21
K060322	Cliniqa Corporation	CLINIQA DRY QC CHEMISTRY CONTROL, LEVELS 1 AND 2, ASSAYED, CLINIQA DRY QC CHEMISTRY CONTROL, LEVEL 1 AND 2 UNASSAYED	2006-03-21
K081789	Siemens Healthcare Diagnostics, Inc.	DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR	2008-09-10
K103836	Siemens Healthcare Diagnostics, Inc.	ENZYME II CALIBRATOR	2011-02-16
K103548	Siemens Healthcare Diagnostics, Inc.	ADVIA CENTAUR CALIBARATOR 80 MODEL 10492491	2011-06-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0024-2007	Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila	2	FSH Calibrators (LN 9C06-01), for in vitro diagnostic use.
Z-0024-2015	Siemens Healthcare Diagnostics, Inc.	2	Dimension Vista Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product for the calibration of Creatine Kinase MB Isoenzyme (MMB) method on the Dimension Vista System.
Z-0025-2007	Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila	2	Architect FSH Calibrators (LN 6C24-01), for in vitro diagnostic use.
Z-0101-2021	Siemens Healthcare Diagnostics, Inc.	2	ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA Chemistry systems Siemens Material Number (SMN): 10361941
Z-0102-2021	Siemens Healthcare Diagnostics, Inc.	2	Atellica CH Systems Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA Chemistry systems Siemens Material Number (SMN): 11097637

Similar Registrations

Registration Number	Establishment Name	Location
3005333358	ABBOTT LABORATORIES	Lake Forest, IL, US
2432235	Siemens Healthcare Diagnostics Inc.	Tarrytown, NY, US
2245285	DRG International, Inc.	Springfield, NJ, US
3003559191	Tecan Trading AG	Maennedorf Zurich, CH
3022178699	IMMUNOCENTRIX CORPORATION	Canoga Park, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9710337. Last updated year: 2026. Please use registration number 9710337 when referencing this establishment in official correspondence.