Ibl I N T G M B H

FDA Filings

This page includes the latest FDA filings for Ibl I N T G M B H. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 9710337
• FEI Number: 3002676602
• Name: IBL INTERNATIONAL GMBH
• Owner & Operator: Tecan Group AG
• Contact Address: 103 Seestrasse --; Maennedorf CH-ZH Zurich 8708 CH
• Official Correspondent:
  • Claudia Solimeo Meneghisse
  • 41-044-922-8992
• US Agent:
  • Laura Nea
  • Tecan U.S.
  • 919 3615200 19524
  • 919 3615201
  • regulatory.affairs.us@tecan.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: FLUGHAFENSTRASSE, 52A ; HAMBURG Hamburg, D-22335 DE
• Establishment Type:
  • Manufacture Medical Device
  • Repack or Relabel Medical Device

FDA Filings

Device Company	Device	Date
GUDID 04049325033627 IBL International GmbH	17-OH-Progesterone ELISA 30223011	2024-04-11
GUDID 04049325030541 IBL International GmbH	17beta-Estradiol Saliva Luminescence Immunoassay RE62149	2023-10-09
GUDID 04049325030534 IBL International GmbH	17beta-Estradiol Saliva Luminescence Immunoassay RE62141	2023-10-09
GUDID 04049325030558 IBL International GmbH	17beta-Estradiol Saliva ELISA 30121045	2023-03-17
GUDID 04049325017214 IBL International GmbH	17beta-Estradiol Saliva ELISA 30121045	2021-01-06
GUDID 04049325014879 IBL International GmbH	Unassayed Testosterone QC Material 30108902	2021-01-06
GUDID 04049325012363 IBL International GmbH	17beta-Estradiol Saliva Luminescence Immunoassay RE62149	2021-01-06
GUDID 04049325012356 IBL International GmbH	17beta-Estradiol Saliva Luminescence Immunoassay RE62141	2021-01-06
GUDID 04049325003613 IBL International GmbH	SaliCaps RE69995.	2021-01-06
GUDID 04049325003606 IBL International GmbH	SaliCaps RE69991.	2021-01-06
GUDID 04049325003538 IBL International GmbH	Progesterone Luminescence Immunoassay RE62029	2021-01-06
GUDID 04049325003521 IBL International GmbH	Progesterone Luminescence Immunoassay RE62021	2021-01-06
GUDID 04049325001787 IBL International GmbH	DHEA-S ELISA RE52181	2021-01-06
GUDID 04049325006546 IBL International GmbH	Testosterone Luminescence Immunoassay RE62039.	2020-10-28
GUDID 04049325003545 IBL International GmbH	Testosterone Luminescence Immunoassay RE62031	2020-10-28
GUDID 04049325008304 IBL International GmbH	Active-B12 (Holotranscobalamin) ELISA AX53101	2018-03-29
GUDID 04049325007734 IBL International GmbH	Cortisol Saliva Luminescence Immunoassay RE62119	2018-03-29
GUDID 04049325007727 IBL International GmbH	Cortisol Saliva Luminescence Immunoassay RE62111	2018-03-29
GUDID 04049325001428 IBL International GmbH	Acetylcholine Receptor Autoantibodies (ARAb) RRA RE21023	2018-03-29
GUDID 04049325001404 IBL International GmbH	Acetylcholine Receptor Autoantibodies (ARAb) RRA RE21021	2018-03-29
PMN K150528 | NHG IBL INTERNATIONAL GMBH [Tecan Group AG]	Cortisol Saliva Luminescence Immunoassay	2016-11-01
PMN K121946 | CDD IBL INTERNATIONAL GMBH [Tecan Group AG]	Active-B12 (Holotranscobalamin) ELISA	2016-11-01
PMN K051144 | NST IBL INTERNATIONAL GMBH [Tecan Group AG]	Acetylcholine Receptor Autoantibodies (ARAb) RRA	2016-11-01
PMN K040923 | JLS IBL INTERNATIONAL GMBH [Tecan Group AG]	SaliCap	2016-11-01
PMN K040923 | JLS IBL INTERNATIONAL GMBH [Tecan Group AG]	Progesterone Luminescence Immunoassay	2016-11-01
PMN K033786 | JJX IBL INTERNATIONAL GMBH [Tecan Group AG]	Unassayed Testosterone QC Material	2016-11-01
PMN K033786 | JJX IBL INTERNATIONAL GMBH [Tecan Group AG]	Testosterone Luminescence Immunoassay	2016-11-01
PMN K033786 | JIT IBL INTERNATIONAL GMBH [Tecan Group AG]	Unassayed Testosterone QC Material	2016-11-01
PMN K033786 | JIT IBL INTERNATIONAL GMBH [Tecan Group AG]	Testosterone Luminescence Immunoassay	2016-11-01
PMN K033786 | CDZ IBL INTERNATIONAL GMBH [Tecan Group AG]	Unassayed Testosterone QC Material	2016-11-01
PMN K033786 | CDZ IBL INTERNATIONAL GMBH [Tecan Group AG]	Testosterone Luminescence Immunoassay	2016-11-01
JKC IBL INTERNATIONAL GMBH [Tecan Group AG]	DHEA-S ELISA	2016-11-01
CHP IBL INTERNATIONAL GMBH [Tecan Group AG]	17beta-Estradiol Saliva Luminescence Immunoassay	2016-11-01
PMN K150528 IBL INTERNATIONAL GMBH	Cortisol Saliva Luminescence Immunoassay	2015-11-25