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IMMUNO CONCEPTS INC

Last updated May 23, 2026

Information

Country: US
Address: —
Website: —
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Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 038271904

Catalogue (387)

Page 2 of 8

Device	Model / Reference	Registries	Class	Status
RELISA® Cardiolipin IgG & IgM Antibody Test	8192	FDA UDI	N/A	Active
Histofluor® Rodent LKS Fluorescent Antibody Test System	12160-04	FDA UDI	N/A	Active
Histofluor® Rodent LKS Fluorescent Antibody Test System	12008-05 (10)	FDA UDI	N/A	Unknown
ANCA Test System	10350-11	FDA UDI	N/A	Active
HEp-2000® IgG Fluorescent ANA-Ro Test System	2075G-Ro (1)	FDA UDI	N/A	Active
Fluorescent nDNA Test System	2004-14	FDA UDI	N/A	Active
ANCA Test System	10350-12	FDA UDI	N/A	Active
RELISA® ENA Multiparameter Antibody Screening Test	7696-09.Au	FDA UDI	N/A	Active
Fluorescent nDNA Test System	3007 (10)	FDA UDI	N/A	Active
HEp-2000® IgG Fluorescent ANA-Ro Test System	2140G-Ro	FDA UDI	N/A	Active
Histofluor® Rodent LKS Fluorescent Antibody Test System	12004-03 (10)	FDA UDI	N/A	Active
Histofluor® Rodent LKS Fluorescent Antibody Test System	12040-05	FDA UDI	N/A	Unknown
Histofluor® Rodent LKS Fluorescent Antibody Test System	12160-02	FDA UDI	N/A	Active
Histofluor® IgA Fluorescent Antibody Test System	12009-01 (1)	FDA UDI	N/A	Active
AUTO I.D.® SSA/Ro and SSB/La Autoantibody Test System	7003 (1)	FDA UDI	N/A	Active
Fluorescent ANA Test System	100	FDA UDI	N/A	Active
ANCA Test System	102100-11	FDA UDI	N/A	Active
Fluorescent ANA Test System	2075 (1)	FDA UDI	N/A	Active
Histofluor® Rodent LKS Fluorescent Antibody Test System	12031 (1)	FDA UDI	N/A	Active
ANCA Test System	10070-12	FDA UDI	N/A	Active
HEp-2000® IgG Fluorescent ANA-Ro Test System	8209-Ro	FDA UDI	N/A	Active
HEp-2000® IgG Fluorescent ANA-Ro Test System	8264-Ro (T)	FDA UDI	N/A	Active
Histofluor® IgG Fluorescent Antibody Test System	12009-10 (1)	FDA UDI	N/A	Active
IMMUNO CONCEPTS Substrate Slide Test Systems	1111 (4)	FDA UDI	N/A	Active
ANCA Test System	10100 (1)	FDA UDI	N/A	Active
HEp-2000® Fluorescent ANA-Ro Test System	2075-Ro (1)	FDA UDI	N/A	Active
Fluorescent ANA Test System	8260	FDA UDI	N/A	Active
Fluorescent ANA Test System	8172.1	FDA UDI	N/A	Unknown
Colorzyme® ANA Test System	4040	FDA UDI	N/A	Active
ANCA Test System	10021-11 (2)	FDA UDI	N/A	Active
HEp-2000® IgG Fluorescent ANA-Ro Test System	2288CS-Ro	FDA UDI	N/A	Active
ANCA Test System	10140-12	FDA UDI	N/A	Active
HEp-2000® Colorzyme® ANA-Ro Test System	4000-18-Ro	FDA UDI	N/A	Active
Immuno Concepts	12262-02R (1)	FDA UDI	N/A	Unknown
Fluorescent nDNA Test System	3200	FDA UDI	N/A	Active
ANCA Test System	8314	FDA UDI	N/A	Active
HEp-2000® Fluorescent ANA-Ro Test System	2700-Ro	FDA UDI	N/A	Active
Histofluor® Rodent LKS Fluorescent Antibody Test System	12160-05	FDA UDI	N/A	Unknown
Histofluor® Rodent LKS Fluorescent Antibody Test System	12800-03	FDA UDI	N/A	Unknown
IgG Anti-nDNA Fluorescent Test System	3040G	FDA UDI	N/A	Active
HEp-2000® Fluorescent ANA-Ro Test System	2004-Ro	FDA UDI	N/A	Active
Histofluor® Rodent LKS Fluorescent Antibody Test System	12008-04 (10)	FDA UDI	N/A	Active
Fluorescent nDNA Test System	3000	FDA UDI	N/A	Active
HEp-2000® IgG Fluorescent ANA-Ro Test System	8217.2-Ro	FDA UDI	N/A	Active
HEp-2000® Fluorescent ANA-Ro Test System	8085-Ro	FDA UDI	N/A	Active
HEp-2000® IgG Fluorescent ANA-Ro Test System	8318-Ro	FDA UDI	N/A	Active
HEp-2000® Fluorescent ANA-Ro Test System	2004-14-Ro	FDA UDI	N/A	Active
HEp-2000® Fluorescent ANA-Ro Test System	2100-Ro	FDA UDI	N/A	Active
IgG Anti-nDNA Fluorescent Test System	3200G (T)	FDA UDI	N/A	Active
HEp-2000® IgG Fluorescent ANA-Ro Test System	8272-Ro	FDA UDI	N/A	Unknown

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FDA Recalls (2)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Dec 4, 2008	Z-1044-2009	—	terminated	Samples can occasionally run out of the wells and cross contaminate adjacent wells.
Nov 25, 2008	Z-1045-2009	—	terminated	In certain patient samples, it is difficult to properly discriminate between anti-Sm/RMP positive samples and samples that are only anti-Sm positive.