Immuno Concepts Na L T D

FDA Filings

This page includes the latest FDA filings for Immuno Concepts Na L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3002810614
• FEI Number: 3002810614
• Name: Immuno Concepts, NA, LTD.
• Owner & Operator: IMMUNO CONCEPTS, INC.
• Contact Address: 9825 Goethe Road Suite 350; Sacramento CA 95827 US
• Official Correspondent:
  • ERIC S HOY, PH.D.
  • x-916-3632649-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 2280 Springlake Road Suite 106; Dallas, TX 75234 US
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

• Registration Number: 2918768
• FEI Number: 2918768
• Name: IMMUNO CONCEPTS, NA, Ltd.
• Owner & Operator: IMMUNO CONCEPTS, INC.
• Contact Address: 9825 Goethe Road Suite 350; Sacramento CA 95827 US
• Official Correspondent:
  • ERIC S HOY, PH.D.
  • x-916-3632649-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 9825 Goethe Rd Ste 350 ; SACRAMENTO, CA 95827 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMN K180202 | PIV IMMUNO CONCEPTS, NA, Ltd. [IMMUNO CONCEPTS, INC.]	Histofluor? Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno Concepts	2019-09-23
PMN K180202 | DBL IMMUNO CONCEPTS, NA, Ltd. [IMMUNO CONCEPTS, INC.]	Histofluor? Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno Concepts	2019-09-23
PMN K180202 Immuno Concepts, NA, Ltd.	Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator By Immuno Concepts	2018-10-19
PMN K160265 | PIV Immuno Concepts, NA, LTD. [IMMUNO CONCEPTS, INC.]	Image Navigator by Immuno Concepts	2016-06-27
PMN K160265 | PIV IMMUNO CONCEPTS, NA, Ltd. [IMMUNO CONCEPTS, INC.]	Image Navigator by Immuno Concepts	2016-06-27
PMN K160265 | DHN Immuno Concepts, NA, LTD. [IMMUNO CONCEPTS, INC.]	Image Navigator by Immuno Concepts	2016-06-27
PMN K160265 | DHN IMMUNO CONCEPTS, NA, Ltd. [IMMUNO CONCEPTS, INC.]	Image Navigator by Immuno Concepts	2016-06-27
PMN K160265 Immuno Concepts, NA, Ltd.	Image Navigator By Immuno Concepts	2016-06-17
PMN K992041 | LJM IMMUNO CONCEPTS, NA, Ltd. [IMMUNO CONCEPTS, INC.]	RELISA ANA Screening Test	2007-12-22
PMN K983924 | DHN IMMUNO CONCEPTS, NA, Ltd. [IMMUNO CONCEPTS, INC.]	HEp-2000 Colorzyme (SSA Confirm)	2007-12-22
PMN K974478 | MOB IMMUNO CONCEPTS, NA, Ltd. [IMMUNO CONCEPTS, INC.]	ANCA Ethanol Fluorescent	2007-12-22
PMN K974463 | MOB IMMUNO CONCEPTS, NA, Ltd. [IMMUNO CONCEPTS, INC.]	ANCA Formalin Fluorescent	2007-12-22
PMN K972145 | DHN IMMUNO CONCEPTS, NA, Ltd. [IMMUNO CONCEPTS, INC.]	HEP-2000 Fluorescent (SSA Confirm)	2007-12-22
PMN K963275 | LLL IMMUNO CONCEPTS, NA, Ltd. [IMMUNO CONCEPTS, INC.]	RELISA ENA Single Well Screen	2007-12-22
PMN K955605 | LLL IMMUNO CONCEPTS, NA, Ltd. [IMMUNO CONCEPTS, INC.]	RELISA Jo-1	2007-12-22
PMN K955604 | LLL IMMUNO CONCEPTS, NA, Ltd. [IMMUNO CONCEPTS, INC.]	RELISA Sm/RNP	2007-12-22
PMN K955603 | LLL IMMUNO CONCEPTS, NA, Ltd. [IMMUNO CONCEPTS, INC.]	RELISA SSA/SSB	2007-12-22
PMN K955602 | LLL IMMUNO CONCEPTS, NA, Ltd. [IMMUNO CONCEPTS, INC.]	RELISA Scl-70	2007-12-22
PMN K950979 | DHN IMMUNO CONCEPTS, NA, Ltd. [IMMUNO CONCEPTS, INC.]	HEp-2000 Colorzyme ANA-Ro	2007-12-22
PMN K944096 | DHN IMMUNO CONCEPTS, NA, Ltd. [IMMUNO CONCEPTS, INC.]	HEp-2000 Fluorescent ANA-Ro	2007-12-22
PMN K935129 | LLL IMMUNO CONCEPTS, NA, Ltd. [IMMUNO CONCEPTS, INC.]	RELISA ENA Multiparameter	2007-12-22
PMN K932225 | MID IMMUNO CONCEPTS, NA, Ltd. [IMMUNO CONCEPTS, INC.]	RELISA Cardiolipin Antibody Screen	2007-12-22
PMN K912489 | LSE IMMUNO CONCEPTS, NA, Ltd. [IMMUNO CONCEPTS, INC.]	EBV-EA Colorzyme	2007-12-22
PMN K912488 | LSE IMMUNO CONCEPTS, NA, Ltd. [IMMUNO CONCEPTS, INC.]	EBV-EA Fluorescet	2007-12-22
PMN K911661 | MID IMMUNO CONCEPTS, NA, Ltd. [IMMUNO CONCEPTS, INC.]	RELISA Cardiolipin IgG & IgM Test	2007-12-22
PMN K895708 | LLM IMMUNO CONCEPTS, NA, Ltd. [IMMUNO CONCEPTS, INC.]	EBNA Fluorescent	2007-12-22
PMN K895707 | LLM IMMUNO CONCEPTS, NA, Ltd. [IMMUNO CONCEPTS, INC.]	EBNA Colorzyme	2007-12-22
PMN K880886 | LJN IMMUNO CONCEPTS, NA, Ltd. [IMMUNO CONCEPTS, INC.]	EBV-VCA IgM Fluorescent	2007-12-22
PMN K880885 | GNP IMMUNO CONCEPTS, NA, Ltd. [IMMUNO CONCEPTS, INC.]	EBV-VCA IgG Colorzyme	2007-12-22
PMN K880884 | LJN IMMUNO CONCEPTS, NA, Ltd. [IMMUNO CONCEPTS, INC.]	EBV-VCA IgM Colorzyme	2007-12-22
PMN K880883 | GNP IMMUNO CONCEPTS, NA, Ltd. [IMMUNO CONCEPTS, INC.]	EBV-VCA IgG Fluorescent	2007-12-22
PMN K860644 | LLL IMMUNO CONCEPTS, NA, Ltd. [IMMUNO CONCEPTS, INC.]	AUTO ID SSA/SSB Autoantibody System	2007-12-22
PMN K860428 | LLL IMMUNO CONCEPTS, NA, Ltd. [IMMUNO CONCEPTS, INC.]	AUTO ID Sm/RNP Autoantibody Test Sy	2007-12-22
PMN K843225 | DHN IMMUNO CONCEPTS, NA, Ltd. [IMMUNO CONCEPTS, INC.]	Colorzyme nDNA Test System	2007-12-22
PMN K833148 | LJM IMMUNO CONCEPTS, NA, Ltd. [IMMUNO CONCEPTS, INC.]	Colorzyme ANA Test System	2007-12-22
PMN K030775 | LKJ IMMUNO CONCEPTS, NA, Ltd. [IMMUNO CONCEPTS, INC.]	AUTO ID Optional Controls	2007-12-22
PMN K013432 | KTL IMMUNO CONCEPTS, NA, Ltd. [IMMUNO CONCEPTS, INC.]	IgG Anti-nDNA Fluorescent Test	2007-12-22
PMN K013285 | MOB IMMUNO CONCEPTS, NA, Ltd. [IMMUNO CONCEPTS, INC.]	RELISA MPO ANCA	2007-12-22
PMN K013283 | MOB IMMUNO CONCEPTS, NA, Ltd. [IMMUNO CONCEPTS, INC.]	RELISA PR3 ANCA	2007-12-22
PMN K810301 | DHN IMMUNO CONCEPTS, NA, Ltd. [IMMUNO CONCEPTS, INC.]	Fluorescent nDNA Test System	2007-12-19
PMN K803276 | DHN IMMUNO CONCEPTS, NA, Ltd. [IMMUNO CONCEPTS, INC.]	Fluorescent ANA Test System	2007-12-19