Data / Medical devices / United States / IMMUNO CONCEPTS, NA, Ltd.

IMMUNO CONCEPTS, NA, Ltd.: FDA-registered device maker in Sacramento, CA, United States, 35 510(k) clearances

Name: IMMUNO CONCEPTS, NA, Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

IMMUNO CONCEPTS, NA, Ltd. is registered with the FDA (registration 2918768) in Sacramento, CA, United States. It lists 13 device types. The FDA files 35 510(k) clearances under its listings, the newest dated October 19, 2018. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 2918768
Address: 9825 Goethe Rd Ste 350, Sacramento, CA, United States, 95827
Owner or operator: Immuno Concepts (2918768)
Roles: Manufacturer
First device listed: December 19, 2007
Registered through: 2026
Brand names listed: ANCA Ethanol Fluorescent, ANCA Formalin Fluorescent, AUTO ID Optional Controls, AUTO ID SSA/SSB Autoantibody System, AUTO ID Sm/RNP Autoantibody Test Sy, Colorzyme ANA Test System, Colorzyme nDNA Test System, EBNA Colorzyme and more

Devices it lists

Device	Product code	Class	Role	Source
Anti-Dna Indirect Immunofluorescent Solid Phase	KTL	2	Manufacturer	accessdata.fda.gov
Antibody Igm, If, Epstein-Barr Virus	LJN	1	Manufacturer	accessdata.fda.gov
Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls	LJM	2	Manufacturer	accessdata.fda.gov
Antinuclear Antibody, Antigen, Control	LKJ	2	Manufacturer	accessdata.fda.gov
Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control	DHN	2	Manufacturer	accessdata.fda.gov
Antiserum, Cf, Epstein-Barr Virus	GNP	1	Manufacturer	accessdata.fda.gov
Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use	PIV	2	Manufacturer	accessdata.fda.gov
Epstein-Barr Virus, Other	LSE	1	Manufacturer	accessdata.fda.gov
Extractable Antinuclear Antibody, Antigen And Control	LLL	2	Manufacturer	accessdata.fda.gov
Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control	DBL	2	Manufacturer	accessdata.fda.gov
System, Test, Anticardiolipin Immunological	MID	2	Manufacturer	accessdata.fda.gov
Test System, Antineutrophil Cytoplasmic Antibodies (Anca)	MOB	2	Manufacturer	accessdata.fda.gov
Test, Antigen, Nuclear, Epstein-Barr Virus	LLM	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
October 19, 2018	K180202	Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno Concepts	DBL	Substantially Equivalent	Immuno Concepts, N.A. , Ltd.	accessdata.fda.gov
June 17, 2016	K160265	Image Navigator by Immuno Concepts	DHN	Substantially Equivalent	Immuno Concepts, N.A. , Ltd.	accessdata.fda.gov
May 12, 2003	K030775	AUTO I.D. JO-1, SCL-70 & PCNA POSITIVE CONTROL SERUM	LKJ	Substantially Equivalent	Immuno Concepts, N.A. , Ltd.	accessdata.fda.gov
November 29, 2001	K013432	IGG ANTI-NDNA FLUORESCENT TEST SYSTEM; MODEL # 3040G	KTL	Substantially Equivalent	Immuno Concepts, Inc.	accessdata.fda.gov
November 14, 2001	K013285	RELISA MPO-ANCA TEST SYSTEM FOR ANTIBODIES TO MYELOPEROXIDASE, MODEL # 7096-15	MOB	Substantially Equivalent	Immuno Concepts, Inc.	accessdata.fda.gov
November 14, 2001	K013283	RELISA PR3-ANCA TEST SYSTEM FOR ANTIBODIES TO PROTEINASE 3, MODEL # 7096-16	MOB	Substantially Equivalent	Immuno Concepts, Inc.	accessdata.fda.gov
July 23, 1999	K992041	RELISA ANA SCREENING TEST SYSTEM, MODEL 7096-11	LJM	Substantially Equivalent	Immuno Concepts, Inc.	accessdata.fda.gov
December 18, 1998	K983924	HEP-2000 COLORZYME ANA-RO TEST SYSTEM, MODEL 4200-RO	DHN	Substantially Equivalent	Immuno Concepts, Inc.	accessdata.fda.gov
February 24, 1998	K972145	HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM	DHN	Substantially Equivalent	Immuno Concepts, Inc.	accessdata.fda.gov
February 9, 1998	K974478	IMMUNO CONCEPTS ANCA TEST SYSTEMS	MOB	Substantially Equivalent	Immuno Concepts, Inc.	accessdata.fda.gov
February 9, 1998	K974463	IMMUNO CONCEPTS ANCA TEST SYSTEM	MOB	Substantially Equivalent	Immuno Concepts, Inc.	accessdata.fda.gov
September 13, 1996	K963275	RELISA ENA SINGLE WELL SCREEN ANTIBODY TEST SYSTEM	LLL	Substantially Equivalent	Immuno Concepts, Inc.	accessdata.fda.gov
April 19, 1996	K955605	RELISA JO-1 ANTIBODY TEST SYSTEM	LLL	Substantially Equivalent	Immuno Concepts, Inc.	accessdata.fda.gov
April 19, 1996	K955604	RELISA SM/RNP ANTIBODY TEST SYSTEM	LLL	Substantially Equivalent	Immuno Concepts, Inc.	accessdata.fda.gov
April 19, 1996	K955603	RELSIA SS-A/RO & SS/B LA ANTIBODY TEST SYSTEM	LLL	Substantially Equivalent	Immuno Concepts, Inc.	accessdata.fda.gov
April 19, 1996	K955602	RELSIA SCL-70 ANTIBODY TEST SYSTEM	LLL	Substantially Equivalent	Immuno Concepts, Inc.	accessdata.fda.gov
June 1, 1995	K950979	HEP-2000 COLORZYME ANA-RO TEST SYSTEM	DHN	Substantially Equivalent	Immuno Concepts, Inc.	accessdata.fda.gov
November 21, 1994	K944096	HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM	DHN	Substantially Equivalent	Immuno Concepts, Inc.	accessdata.fda.gov
January 31, 1994	K935129	RELISA ENA ANTIBODY SCREENING TEST SYSTEM	LLL	Substantially Equivalent	Immuno Concepts, Inc.	accessdata.fda.gov
July 6, 1993	K932225	ANTI-CARDIOLIPIN ANTIBODY SCREENING TEST SYSTEM	MID	Substantially Equivalent	Immuno Concepts, Inc.	accessdata.fda.gov
December 9, 1991	K911661	ANTI-CARDIOLIPIN ANTIBODY TEST SYSTEM	MID	Substantially Equivalent	Immuno Concepts, Inc.	accessdata.fda.gov
July 24, 1991	K912489	COLORZYME EBV EARLY ANTIGEN IGG ANTIBODY TEST SYS	LSE	Substantially Equivalent	Immuno Concepts, Inc.	accessdata.fda.gov
July 24, 1991	K912488	FLUORECENT EBV-EARLY ANTIGEN IGG ANTIBODY TEST SYS	LSE	Substantially Equivalent	Immuno Concepts, Inc.	accessdata.fda.gov
December 11, 1989	K895708	EBNA ANTIBODY TEST SYSTEM (IMMUNOFLUORESCENT ANTI)	LLM	Substantially Equivalent	Immuno Concepts, Inc.	accessdata.fda.gov
December 8, 1989	K895707	EBNA ANTIBODY TEST SYSTEM (IMMUNOENZYME ANTIBODY)	LLM	Substantially Equivalent	Immuno Concepts, Inc.	accessdata.fda.gov
August 30, 1988	K880886	EBV-VCA IGM ANTIBODY TEST SYSTEM (FLUORESCENT)	LJN	Substantially Equivalent	Immuno Concepts, Inc.	accessdata.fda.gov
August 30, 1988	K880885	EBV-VCA IGG ANTIBODY TEST SYSTEM (ENZYME)	GNP	Substantially Equivalent	Immuno Concepts, Inc.	accessdata.fda.gov
August 30, 1988	K880884	EBV-VCA IGM ANTIBODY TEST SYSTEM (ENZYME)	LJN	Substantially Equivalent	Immuno Concepts, Inc.	accessdata.fda.gov
August 30, 1988	K880883	EBV-VCA IGG ANTIBODY TEST SYSTEM (FLUORESCENT)	GNP	Substantially Equivalent	Immuno Concepts, Inc.	accessdata.fda.gov
May 15, 1986	K860428	SM-RNP AUTOANTIBODY TEST SYSTEM	LLL	Substantially Equivalent	Immuno Concepts, Inc.	accessdata.fda.gov
March 28, 1986	K860644	SS-A/SS-B AUTOANTIBODY TEST SYSTEM	LLL	Substantially Equivalent	Immuno Concepts, Inc.	accessdata.fda.gov
November 1, 1984	K843225	COLORZYME NDNA TEST SYSTEM	DHN	Substantially Equivalent	Immuno Concepts, Inc.	accessdata.fda.gov
November 21, 1983	K833148	ENZYME ANA TEST SYSTEM	LJM	Substantially Equivalent	Immuno Concepts, Inc.	accessdata.fda.gov
February 25, 1981	K810301	CRITHIDIA LUCILIAE NATIVE DNA-IFA TEST	DHN	Substantially Equivalent	Immuno Concepts, Inc.	accessdata.fda.gov
January 26, 1981	K803276	ANA-IFA TEST SYSTEM	DHN	Substantially Equivalent	Immuno Concepts, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
December 4, 2008	50518	Not yet classified	Terminated	ANA Fluorescent Test System and ANA Colorzyme Test System, Sub assembly catalog number SA 2013, Kit Catalog Numbers, 2000, 2002, 2003, 2004, 2005, 2100, 2200, 4000, 4200, 8024.1, and 8060, manufactured by Immuno Concepts	Samples can occasionally run out of the wells and cross contaminate adjacent wells.	accessdata.fda.gov
November 25, 2008	50519	Not yet classified	Terminated	RELISA ENA Multiparameter Antibody Screening test, enzyme immunoassay test system, manufactured by Immuno Concepts N.A. Ltd., Sacramento, CA.	In certain patient samples, it is difficult to properly discriminate between anti-Sm/RMP positive samples and samples that are only anti-Sm positive.	accessdata.fda.gov

Compare with other makers

Updated October 19, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.