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IMMUNO CONCEPTS INC

Last updated May 23, 2026

Information

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

Catalogue (387)

Page 1 of 8

Device	Model / Reference	Registries	Class	Status
RELISA® PR3-ANCA Test System for Antibodies to Proteinase 3	7096-16	FDA UDI	N/A	Active
AUTO I.D.® Sm/RNP Autoantibody Test System	6060	FDA UDI	N/A	Active
HEp-2000® IgG Fluorescent ANA-Ro Test System	2075B (1)	FDA UDI	N/A	Active
ANCA Test System	10031 (2)	FDA UDI	N/A	Active
Fluorescent nDNA Test System	3014 (10)	FDA UDI	N/A	Active
HEp-2000® IgG Fluorescent ANA-Ro Test System	2280CS-Ro (T)	FDA UDI	N/A	Active
Fluorescent ANA Test System	2140CS	FDA UDI	N/A	Active
ANCA-L Test System	10700L-11	FDA UDI	N/A	Active
Fluorescent ANA Test System	2004CS	FDA UDI	N/A	Active
HEp-2000® IgG Fluorescent ANA-Ro Test System	2280G-Ro	FDA UDI	N/A	Active
IgG Anti-nDNA Fluorescent Test System	8197	FDA UDI	N/A	Active
HEp-2000® Fluorescent ANA-Ro Test System	2037 (1)	FDA UDI	N/A	Active
HEp-2000® IgG Fluorescent ANA-Ro Test System	8193.1-Ro	FDA UDI	N/A	Active
HEp-2000® Fluorescent ANA-Ro Test System	8029-Ro	FDA UDI	N/A	Active
Colorzyme® ANA Test System	4200	FDA UDI	N/A	Active
Histofluor® Rodent LKS Fluorescent Antibody Test System	12080-03	FDA UDI	N/A	Unknown
HEp-2000® IgG Fluorescent ANA-Ro Test System	8251.3-Ro	FDA UDI	N/A	Unknown
IgG Anti-nDNA Fluorescent Test System	3200G	FDA UDI	N/A	Active
HEp-2000® Fluorescent ANA-Ro Test System	2041 (1)	FDA UDI	N/A	Active
HEp-2000® Fluorescent ANA-Ro Test System	200	FDA UDI	N/A	Active
Histofluor® IgG Fluorescent Antibody Test System	12009-10 (1)	FDA UDI	N/A	Active
Fluorescent ANA Test System	1000	FDA UDI	N/A	Active
Immuno Concepts	12031R (1)	FDA UDI	N/A	Unknown
HEp-2000® IgG Fluorescent ANA-Ro Test System	2075CS (1)	FDA UDI	N/A	Active
RELISA® Cardiolipin IgG & IgM Antibody Test	7096-02	FDA UDI	N/A	Active
HEp-2000® IgG Fluorescent ANA-Ro Test System	8290-Ro	FDA UDI	N/A	Active
Colorzyme® nDNA Test System	5200	FDA UDI	N/A	Active
AUTO I.D.® Sm/RNP Autoantibody Test System	6002 (1)	FDA UDI	N/A	Active
Colorzyme® nDNA Test System	5000	FDA UDI	N/A	Active
RELISA® ANA Screening Test System	7096-11	FDA UDI	N/A	Active
RELISA® Cardiolipin Antibody Screening Test	7096-01	FDA UDI	N/A	Unknown
Fluorescent nDNA Test System	2200-Ro	FDA UDI	N/A	Active
HEp-2000® Fluorescent ANA-Ro Test System	8149.1-Ro	FDA UDI	N/A	Active
Fluorescent ANA Test System	8067	FDA UDI	N/A	Active
HEp-2000® IgG Fluorescent ANA-Ro Test System	8275-Ro	FDA UDI	N/A	Active
HEp-2000® IgG Fluorescent ANA-Ro Test System	2004G-14-Ro	FDA UDI	N/A	Active
HEp-2000® IgG Fluorescent ANA-Ro Test System	2000CS-14-Ro	FDA UDI	N/A	Active
Histofluor® Primate Esophagus Autoantibody Fluorescent Test System	12004-01 (10)	FDA UDI	N/A	Active
Histofluor® Rodent LKS Fluorescent Antibody Test System	12262-02 (1)	FDA UDI	N/A	Active
HEp-2000® Fluorescent ANA-Ro Test System	8262-Ro (T)	FDA UDI	N/A	Active
HEp-2000® IgG Fluorescent ANA-Ro Test System	2004G-21-Ro	FDA UDI	N/A	Active
Colorzyme® ANA Test System	4075 (1)	FDA UDI	N/A	Active
AUTO I.D.® SSA/Ro and SSB/La Autoantibody Test System	6004 (1)	FDA UDI	N/A	Active
HEp-2000® IgG Fluorescent ANA-Ro Test System	8270-Ro	FDA UDI	N/A	Active
HEp-2000® Fluorescent ANA-Ro Test System	2026 (1)	FDA UDI	N/A	Active
IgG Anti-nDNA Fluorescent Test System	3005G	FDA UDI	N/A	Active
HEp-2000® IgG Fluorescent ANA-Ro Test System	8400CS-Ro	FDA UDI	N/A	Active
RELISA® Cardiolipin Antibody Screening Test	7696-01	FDA UDI	N/A	Unknown
Fluorescent ANA Test System	8021.1	FDA UDI	N/A	Active
HEp-2000® IgG Fluorescent ANA-Ro Test System	8298-Ro	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.