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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 6 of 8

Device	Model / Reference	Registries	Class	Status
Fluorescent ANA Test System	8060	FDA UDI	N/A	Active
HEp-2 Fluorescent w/cs ANA Test System	2280B	FDA UDI	N/A	Active
AUTO I.D.® Sm/RNP Autoantibody Test System	7010 (10)	FDA UDI	N/A	Active
Fluorescent ANA Test System	2000-14	FDA UDI	N/A	Active
ANCA Test System	8309	FDA UDI	N/A	Active
Immuno Concepts	8131	FDA UDI	N/A	Unknown
HEp-2000® IgG Fluorescent ANA-Ro Test System	8216-Ro (T)	FDA UDI	N/A	Active
Fluorescent nDNA Test System	3075 (1)	FDA UDI	N/A	Active
HEp-2000® IgG Fluorescent ANA-Ro Test System	8264-Ro	FDA UDI	N/A	Active
Fluorescent ANA Test System	2200	FDA UDI	N/A	Active
Fluorescent ANA Test System	2005	FDA UDI	N/A	Active
HEp-2000® Fluorescent ANA-Ro Test System	8248-Ro	FDA UDI	N/A	Active
Fluorescent ANA Test System	8276	FDA UDI	N/A	Active
Fluorescent ANA Test System	2040CS	FDA UDI	N/A	Active
Immuno Concepts	12040-02R	FDA UDI	N/A	Unknown
HEp-2000® Fluorescent ANA-Ro Test System	8153-Ro	FDA UDI	N/A	Active
Fluorescent ANA Test System	8311.2	FDA UDI	N/A	Active
HEp-2000® IgG Fluorescent ANA-Ro Test System	8263-Ro	FDA UDI	N/A	Active
Histofluor® Rodent LKS Fluorescent Antibody Test System	12022-02 (1)	FDA UDI	N/A	Active
HEp-2000® IgG Fluorescent ANA-Ro Test System	8286-Ro	FDA UDI	N/A	Active
Fluorescent nDNA Test System	8122	FDA UDI	N/A	Active
Histofluor® Rodent LKS Fluorescent Antibody Test System	12040-04	FDA UDI	N/A	Active
Histofluor® Rodent LKS Fluorescent Antibody Test System	12800-02	FDA UDI	N/A	Unknown
HEp-2000® IgG Fluorescent ANA-Ro Test System	8216-Ro	FDA UDI	N/A	Active
IgG Anti-nDNA Fluorescent Test System	3075G (1)	FDA UDI	N/A	Active
Fluorescent ANA Test System	8261	FDA UDI	N/A	Active
Fluorescent nDNA Test System	3031 (1)	FDA UDI	N/A	Active
ANCA Test System	10070-11	FDA UDI	N/A	Active
RELISA® ENA Single Well Screening Test	7696-10	FDA UDI	N/A	Active
HEp-2000® Fluorescent ANA-Ro Test System	2032	FDA UDI	N/A	Active
HEp-2000® IgG Fluorescent ANA-Ro Test System	2075GCS-Ro (1)	FDA UDI	N/A	Active
Fluorescent ANA Test System	8019	FDA UDI	N/A	Active
IMMUNO CONCEPTS Substrate Slide Test Systems	1042 (1)	FDA UDI	N/A	Active
Fluorescent ANA Test System	2004CS-14	FDA UDI	N/A	Active
Colorzyme® ANA Test System	4000	FDA UDI	N/A	Active
HEp-2000® Fluorescent ANA-Ro Test System	2002-Ro	FDA UDI	N/A	Active
Histofluor® Rodent LKS Fluorescent Antibody Test System	12022-02R (1)	FDA UDI	N/A	Unknown
RELISA® anti-dsDNA Test System	7096-17	FDA UDI	N/A	Active
Fluorescent ANA Test System	2014 (10)	FDA UDI	N/A	Active
HEp-2000® Fluorescent ANA-Ro Test System	2031 (1)	FDA UDI	N/A	Active
IMMUNO CONCEPTS Test Systems	1012 (20)	FDA UDI	N/A	Active
HEp-2000® IgG Fluorescent ANA-Ro Test System	2000CS-18-Ro	FDA UDI	N/A	Active
Fluorescent ANA Test System	8317	FDA UDI	N/A	Active
HEp-2000® Fluorescent ANA-Ro Test System	8295-Ro	FDA UDI	N/A	Active
Histofluor® Rodent LKS Fluorescent Antibody Test System	12080-03 (T)	FDA UDI	N/A	Active
Fluorescent ANA Test System	8121.1	FDA UDI	N/A	Active
Histofluor® Primate Esophagus Autoantibody Fluorescent Test System	12400-01	FDA UDI	N/A	Active
HEp-2000® IgG Fluorescent ANA-Ro Test System	8321-Ro	FDA UDI	N/A	Active
HEp-2000® Fluorescent ANA-Ro Test System	8400	FDA UDI	N/A	Active
Histofluor® Primate Esophagus Autoantibody Fluorescent Test System	12040-01	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.