Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2918768

FEI Number

2918768

Entity Name

IMMUNO CONCEPTS, NA, Ltd.

City/State/Country

SACRAMENTO, CA, US

Establishment Address

9825 Goethe Rd Ste 350, SACRAMENTO, CA 95827, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Immuno Concepts (Owner Number: 2918768)

Owner / Operator Contact Address

9825 Goethe Road, Suite 350, Sacramento, CA 95827, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K013432

PMA Number

N/A

All Registered Proprietary Names

EBV-EA Fluorescet EBV-EA Colorzyme RELISA PR3 ANCA ANCA Ethanol Fluorescent Colorzyme nDNA Test System HEp-2000 Colorzyme (SSA Confirm) HEP-2000 Fluorescent (SSA Confirm) Fluorescent ANA Test System EBV-VCA IgM Colorzyme RELISA ENA Multiparameter RELISA MPO ANCA RELISA ANA Screening Test AUTO ID Sm/RNP Autoantibody Test Sy EBV-VCA IgM Fluorescent AUTO ID SSA/SSB Autoantibody System RELISA Jo-1 Image Navigator by Immuno Concepts RELISA Cardiolipin IgG & IgM Test HEp-2000 Fluorescent ANA-Ro EBNA Fluorescent EBV-VCA IgG Colorzyme Histofluor® Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno Concepts RELISA Scl-70 RELISA Cardiolipin Antibody Screen AUTO ID Optional Controls RELISA SSA/SSB IgG Anti-nDNA Fluorescent Test

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LSE	Epstein-Barr Virus, Other	Microbiology	Class 1	866.3235	2007-12-22
LSE	Epstein-Barr Virus, Other	Microbiology	Class 1	866.3235	2007-12-22
MOB	Test System, Antineutrophil Cytoplasmic Antibodies (Anca)	Immunology	Class 2	866.5660	2007-12-22
MOB	Test System, Antineutrophil Cytoplasmic Antibodies (Anca)	Immunology	Class 2	866.5660	2007-12-22
DHN	Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control	Immunology	Class 2	866.5100	2007-12-22
DHN	Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control	Immunology	Class 2	866.5100	2007-12-22
DHN	Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control	Immunology	Class 2	866.5100	2007-12-22
DHN	Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control	Immunology	Class 2	866.5100	2007-12-19
LJN	Antibody Igm, If, Epstein-Barr Virus	Microbiology	Class 1	866.3235	2007-12-22
LLL	Extractable Antinuclear Antibody, Antigen And Control	Immunology	Class 2	866.5100	2007-12-22
MOB	Test System, Antineutrophil Cytoplasmic Antibodies (Anca)	Immunology	Class 2	866.5660	2007-12-22
LJM	Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls	Immunology	Class 2	866.5100	2007-12-22
LLL	Extractable Antinuclear Antibody, Antigen And Control	Immunology	Class 2	866.5100	2007-12-22
LJN	Antibody Igm, If, Epstein-Barr Virus	Microbiology	Class 1	866.3235	2007-12-22
LLL	Extractable Antinuclear Antibody, Antigen And Control	Immunology	Class 2	866.5100	2007-12-22
LLL	Extractable Antinuclear Antibody, Antigen And Control	Immunology	Class 2	866.5100	2007-12-22
PIV	Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use	Immunology	Class 2	866.4750	2016-06-27
DHN	Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control	Immunology	Class 2	866.5100	2016-06-27
MID	System, Test, Anticardiolipin Immunological	Immunology	Class 2	866.5660	2007-12-22
DHN	Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control	Immunology	Class 2	866.5100	2007-12-22
LLM	Test, Antigen, Nuclear, Epstein-Barr Virus	Microbiology	Class 1	866.3235	2007-12-22
GNP	Antiserum, Cf, Epstein-Barr Virus	Microbiology	Class 1	866.3235	2007-12-22
DBL	Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control	Immunology	Class 2	866.5660	2019-09-23
PIV	Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use	Immunology	Class 2	866.4750	2019-09-23
LLL	Extractable Antinuclear Antibody, Antigen And Control	Immunology	Class 2	866.5100	2007-12-22
MID	System, Test, Anticardiolipin Immunological	Immunology	Class 2	866.5660	2007-12-22
LKJ	Antinuclear Antibody, Antigen, Control	Immunology	Class 2	866.5100	2007-12-22
LLL	Extractable Antinuclear Antibody, Antigen And Control	Immunology	Class 2	866.5100	2007-12-22
KTL	Anti-Dna Indirect Immunofluorescent Solid Phase	Immunology	Class 2	866.5100	2007-12-22

Official Correspondent

Nicole Lasquete

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Immuno Concepts

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K880742	Inova Diagnostics, Inc.	NOVA LITE(TM) DSDNA	1988-03-25
K854207	Immuno-Diagnostic Products, Inc.	EBV(EPSTEIN-BARR VIRUS) TEST KIT	1986-04-24
K820088	Calbiochem-Behring Corp.	AFT SYSTEM PROFICIENCY TESTING PROGRAM	1982-01-26
K203599	Immuno Concepts, N.A. , Ltd.	Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test System	2023-05-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0034-2008	Louisville Apl Diagnostics Inc	2	APhL HRP IgG & IgM ELISA Kit; Ref. #LAPL-K-HRP-00GM; in vitro diagnostic. Distributed by Louisville APL Diagnostics, Inc., Doraville, GA 30360 (address now in Seabrook, TX 77856).

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2918768. Last updated year: 2026. Please use registration number 2918768 when referencing this establishment in official correspondence.