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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 7 of 8

Device	Model / Reference	Registries	Class	Status
Fluorescent nDNA Test System	8250.1	FDA UDI	N/A	Active
HEp-2000® IgG Fluorescent ANA-Ro Test System	8278-Ro	FDA UDI	N/A	Active
HEp-2000® IgG Fluorescent ANA-Ro Test System	8251.4-Ro	FDA UDI	N/A	Active
Fluorescent nDNA Test System	3005	FDA UDI	N/A	Active
Fluorescent ANA Test System	2003	FDA UDI	N/A	Active
Fluorescent ANA Test System	2004	FDA UDI	N/A	Active
RELISA® ENA Multiparameter Antibody Screening Test	7096-09	FDA UDI	N/A	Active
HEp-2000® IgG Fluorescent ANA-Ro Test System	8313-Ro	FDA UDI	N/A	Active
Immuno Concepts	7696-12	FDA UDI	N/A	Unknown
Fluorescent ANA Test System	2100	FDA UDI	N/A	Active
RELISA® Cardiolipin IgG & IgM Antibody Test	7696-02	FDA UDI	N/A	Active
Fluorescent ANA Test System	8172.2	FDA UDI	N/A	Active
HEp-2000® Fluorescent ANA-Ro Test System	8096-Ro	FDA UDI	N/A	Active
AUTO I.D.® Sm/RNP Autoantibody Test System	6006 (1)	FDA UDI	N/A	Active
Histofluor® Rodent LKS Fluorescent Antibody Test System	12004-02 (10)	FDA UDI	N/A	Active
Fluorescent nDNA Test System	8299	FDA UDI	N/A	Active
Colorzyme® nDNA Test System	5040	FDA UDI	N/A	Active
HEp-2000® IgG Fluorescent ANA-Ro Test System	8280-Ro	FDA UDI	N/A	Active
Fluorescent nDNA Test System	3021 (1)	FDA UDI	N/A	Active
Fluorescent ANA Test System	M12 (1)	FDA UDI	N/A	Unknown
ANCA BP FA Test System - Ethanol Fixed Substrate - 420 Tests	100420-11	FDA UDI	N/A	Unknown
HEp-2000® IgG Fluorescent ANA-Ro Test System	2200G-14-Ro	FDA UDI	N/A	Active
Fluorescent nDNA Test System	8227	FDA UDI	N/A	Active
ANCA-L Test System	10350L-11	FDA UDI	N/A	Active
HEp-2000® IgG Fluorescent ANA-Ro Test System	2000G-18-Ro	FDA UDI	N/A	Active
ANCA Test System	10021-12 (2)	FDA UDI	N/A	Active
HEp-2000® IgG Fluorescent ANA-Ro Test System	2140B-Ro	FDA UDI	N/A	Active
ANCA Test System	8310	FDA UDI	N/A	Active
HEp-2000® Colorzyme® ANA-Ro Test System	4000-14-Ro	FDA UDI	N/A	Active
HEp-2000® Colorzyme® ANA-Ro Test System	8155.1-Ro	FDA UDI	N/A	Active
Fluorescent ANA Test System	500	FDA UDI	N/A	Active
HEp-2000® IgG Fluorescent ANA-Ro Test System	8232-Ro	FDA UDI	N/A	Active
IMMUNO CONCEPTS Substrate Slide Test Systems	1042 Bulk	FDA UDI	N/A	Active
RELISA® ENA Multiparameter Antibody Screening Test	7696-09	FDA UDI	N/A	Active
Histofluor® Primate Esophagus Autoantibody Fluorescent Test System	12160-01	FDA UDI	N/A	Active
AUTO I.D.® Sm/RNP Autoantibody Test System	6050 (1)	FDA UDI	N/A	Active
HEp-2000® IgG Fluorescent ANA-Ro Test System	8266.1-Ro	FDA UDI	N/A	Active
HEp-2 Fluorescent w/cs ANA Test System	2140B	FDA UDI	N/A	Active
Histofluor® Primate Esophagus Autoantibody Fluorescent Test System	12080-01	FDA UDI	N/A	Active
HEp-2000® IgG Fluorescent ANA-Ro Test System	2145G-Ro	FDA UDI	N/A	Active
HEp-2000® IgG Fluorescent ANA-Ro Test System	8238-Ro	FDA UDI	N/A	Active
HEp-2000® IgG Fluorescent ANA-Ro Test System	2002CS-14-Ro	FDA UDI	N/A	Active
RELISA® Cardiolipin IgG & IgM Antibody Test	8288	FDA UDI	N/A	Active
HEp-2000® IgG Fluorescent ANA-Ro Test System	2672CS-Ro	FDA UDI	N/A	Active
FITC Quality Control Slide ™	1900 (1)	FDA UDI	N/A	Active
HEp-2000® IgG Fluorescent ANA-Ro Test System	8267-Ro	FDA UDI	N/A	Active
HEp-2000® IgG Fluorescent ANA-Ro Test System	8225.2-Ro	FDA UDI	N/A	Active
ANCA-L Test System	10070L-11	FDA UDI	N/A	Active
RELISA® ENA Single Well Screening Test	7696-10.Au	FDA UDI	N/A	Active
Histofluor® IgA Fluorescent Antibody Test System	12021-01 (1)	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.