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IMMUNO CONCEPTS INC

Last updated May 23, 2026

Information

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

Catalogue (387)

Page 5 of 8

Device	Model / Reference	Registries	Class	Status
HEp-2000® IgG Fluorescent ANA-Ro Test System	2014-Ro (10)	FDA UDI	N/A	Active
RELISA® Cardiolipin IgG & IgM Antibody Test	8316	FDA UDI	N/A	Active
Histofluor® Rodent LKS Fluorescent Antibody Test System	12160-02R	FDA UDI	N/A	Unknown
HEp-2000® IgG Fluorescent ANA-Ro Test System	8319-Ro	FDA UDI	N/A	Active
Fluorescent ANA Test System	8311	FDA UDI	N/A	Active
HEp-2000® Fluorescent ANA-Ro Test System	8246-Ro	FDA UDI	N/A	Active
HEp-2000® Colorzyme® ANA-Ro Test System	4040-Ro	FDA UDI	N/A	Active
HEp-2000® Fluorescent ANA-Ro Test System	8224-Ro	FDA UDI	N/A	Active
HEp-2000® IgG Fluorescent ANA-Ro Test System	8178.2-Ro	FDA UDI	N/A	Active
HEp-2000® Fluorescent ANA-Ro Test System	8123-Ro	FDA UDI	N/A	Active
Fluorescent nDNA Test System	3001	FDA UDI	N/A	Active
HEp-2000® Fluorescent ANA-Ro Test System	20100 (1)	FDA UDI	N/A	Active
Fluorescent nDNA Test System	3040	FDA UDI	N/A	Active
RELISA® ENA Multiparameter Antibody Screening Test Sm RNP SSA/Ro SSB/La Scl-70 J	8307	FDA UDI	N/A	Active
Histofluor® Rodent LKS Fluorescent Antibody Test System	12263-02R (1)	FDA UDI	N/A	Unknown
HEp-2000® Fluorescent ANA-Ro Test System	8207.1-Ro	FDA UDI	N/A	Active
RELISA® ENA Multiparameter Antibody Screening Test	7096-09.Au	FDA UDI	N/A	Active
HEp-2000® IgG Fluorescent ANA-Ro Test System	2075B (1)	FDA UDI	N/A	Active
HEp-2000® IgG Fluorescent ANA-Ro Test System	8291-Ro	FDA UDI	N/A	Active
HEp-2000® Fluorescent ANA-Ro Test System	2000-18-Ro	FDA UDI	N/A	Active
HEp-2000® Fluorescent ANA-Ro Test System	2200-14-Ro	FDA UDI	N/A	Active
Histofluor® Rodent LKS Fluorescent Antibody Test System	8289	FDA UDI	N/A	Active
Image Navigator®	IN220	FDA UDI	Class II	Active
Histofluor® Rodent LKS Fluorescent Antibody Test System	12261-02R (1)	FDA UDI	N/A	Unknown
Histofluor® Rodent LKS Fluorescent Antibody Test System	12400-04	FDA UDI	N/A	Unknown
HEp-2000® IgG Fluorescent ANA-Ro Test System	2280CS-Ro	FDA UDI	N/A	Active
Histofluor® Rodent LKS Fluorescent Antibody Test System	12040-02	FDA UDI	N/A	Active
Histofluor® Rodent LKS Fluorescent Antibody Test System	12160-04R	FDA UDI	N/A	Unknown
Fluorescent ANA Test System	2280CS (T)	FDA UDI	N/A	Active
AUTO I.D.® Sm/RNP Autoantibody Test System	6001 (1)	FDA UDI	N/A	Active
ANCA Test System	10026-12 (2)	FDA UDI	N/A	Active
HEp-2000® Fluorescent ANA-Ro Test System	2022 (2)	FDA UDI	N/A	Active
HEp-2000® Fluorescent ANA-Ro Test System	8296-Ro	FDA UDI	N/A	Active
Histofluor® Primate Esophagus Autoantibody Fluorescent Test System	12008-01 (10)	FDA UDI	N/A	Active
HEp-2000® IgG Fluorescent ANA-Ro Test System	2000G-21-Ro	FDA UDI	N/A	Active
Histofluor® Rodent LKS Fluorescent Antibody Test System	12080-02 (T)	FDA UDI	N/A	Active
Histofluor® Rodent LKS Fluorescent Antibody Test System	12075-02 (1)	FDA UDI	N/A	Active
HEp-2000® IgG Fluorescent ANA-Ro Test System	8282-Ro	FDA UDI	N/A	Active
HEp-2000® IgG Fluorescent ANA-Ro Test System	8271-Ro	FDA UDI	N/A	Active
HEp-2000® IgG Fluorescent w/cs ANA-Ro Test System	2280B-Ro	FDA UDI	N/A	Active
IgG Anti-nDNA Fluorescent Test System	8196	FDA UDI	N/A	Active
HEp-2000® Colorzyme® ANA-Ro Test System	8002-Ro	FDA UDI	N/A	Active
Histofluor® Rodent LKS Fluorescent Antibody Test System	12004-04 (10)	FDA UDI	N/A	Active
ANCA Test System	10700-11	FDA UDI	N/A	Active
HEp-2000® Fluorescent ANA-Ro Test System	2035 (1)	FDA UDI	N/A	Active
HEp-2000® IgG Fluorescent ANA-Ro Test System	2140CS-Ro	FDA UDI	N/A	Active
ANCA Test System	10140-12 (T)	FDA UDI	N/A	Active
Histofluor® Primate Esophagus Autoantibody Fluorescent Test System	12080-01R (T)	FDA UDI	N/A	Active
Fluorescent ANA Test System	2000	FDA UDI	N/A	Active
Histofluor® Rodent LKS Fluorescent Antibody Test System	12008-02 (10)	FDA UDI	N/A	Active

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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.