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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 3 of 8

Device	Model / Reference	Registries	Class	Status
ANCA Test System	10009-11 (1)	FDA UDI	N/A	Active
HEp-2000® IgG Fluorescent ANA-Ro Test System	2000CS-21-Ro	FDA UDI	N/A	Active
HEp-2000® Fluorescent ANA-Ro Test System	2029 (1)	FDA UDI	N/A	Active
HEp-2000® IgG Fluorescent ANA-Ro Test System	8269-Ro	FDA UDI	N/A	Active
HEp-2000® Colorzyme® ANA-Ro Test System	4200-Ro	FDA UDI	N/A	Active
HEp-2000® Fluorescent ANA-Ro Test System	8084-Ro	FDA UDI	N/A	Active
Histofluor® Rodent LKS Fluorescent Antibody Test System	12261-02 (1)	FDA UDI	N/A	Active
AUTO I.D.® Sm/RNP Autoantibody Test System	6005 (1)	FDA UDI	N/A	Active
Immuno Concepts	7096-12	FDA UDI	N/A	Unknown
HEp-2000® IgG Fluorescent ANA-Ro Test System	8300CS-Ro	FDA UDI	N/A	Active
HEp-2000® Fluorescent ANA-Ro Test System	8262-Ro	FDA UDI	N/A	Active
HEp-2000® IgG Fluorescent ANA-Ro Test System	8271.1-Ro	FDA UDI	N/A	Active
IMMUNO CONCEPTS RELISA® Test Systems	1031 (4)	FDA UDI	N/A	Active
HEp-2000® Fluorescent ANA-Ro Test System	2040-Ro	FDA UDI	N/A	Active
HEp-2000® IgG Fluorescent ANA-Ro Test System	8244-Ro	FDA UDI	N/A	Active
HEp-2000® Colorzyme® ANA-Ro Test System	4075-Ro (1)	FDA UDI	N/A	Active
HEp-2000® IgG Fluorescent ANA-Ro Test System	8302-Ro	FDA UDI	N/A	Active
HEp-2000® IgG Fluorescent ANA-Ro Test System	2200G-Ro	FDA UDI	N/A	Active
RELISA® ENA Single Well Screening Test	7096-10.Au	FDA UDI	N/A	Active
Histofluor® Rodent LKS Fluorescent Antibody Test System	12023-02 (1)	FDA UDI	N/A	Active
Colorzyme® nDNA Test System	8304	FDA UDI	N/A	Active
Auto I.D.® SSA/Ro and SSB/La Autoantibody Test System	7002 (1)	FDA UDI	N/A	Active
RELISA® ENA Single Well Screening Test	7096-10	FDA UDI	N/A	Active
HEp-2000® IgG Fluorescent ANA-Ro Test System	8252-Ro	FDA UDI	N/A	Active
HEp-2000® IgG Fluorescent ANA-Ro Test System	2000G-14-Ro	FDA UDI	N/A	Active
HEp-2000® IgG Fluorescent ANA-Ro Test System	8285-Ro	FDA UDI	N/A	Active
Colorzyme® nDNA Test System	8011	FDA UDI	N/A	Active
Fluorescent ANA Test System	2007 (10)	FDA UDI	N/A	Active
Histofluor® Rodent LKS Fluorescent Antibody Test System	12080-02	FDA UDI	N/A	Unknown
HEp-2000® IgG Fluorescent ANA-Ro Test System	2280GCS-Ro	FDA UDI	N/A	Active
HEp-2000® Colorzyme® ANA-Ro Test System	4000-Ro	FDA UDI	N/A	Active
HEp-2000® IgG Fluorescent ANA-Ro Test System	8303-Ro	FDA UDI	N/A	Active
ANCA Test System	10700-12	FDA UDI	N/A	Active
Fluorescent ANA Test System	8128.1	FDA UDI	N/A	Active
Fluorescent nDNA Test System	3026 (1)	FDA UDI	N/A	Active
HEp-2000® Fluorescent ANA-Ro Test System	8127-Ro	FDA UDI	N/A	Active
HEp-2000® Fluorescent ANA-Ro Test System	20100 (10)	FDA UDI	N/A	Active
HEp-2000® Fluorescent ANA-Ro Test System	2027 (1)	FDA UDI	N/A	Active
RELISA® MPO-ANCA Antibody Test System	7096-15	FDA UDI	N/A	Active
Histofluor® Rodent LKS Fluorescent Antibody Test System	12023-02R (1)	FDA UDI	N/A	Unknown
HEp-2000® IgG Fluorescent ANA-Ro Test System	8273-Ro	FDA UDI	N/A	Active
Image Navigator®	IN110	FDA UDI	Class II	Active
HEp-2000® Fluorescent ANA-Ro Test System	2000-Ro	FDA UDI	N/A	Active
Histofluor® Rodent LKS Fluorescent Antibody Test System	12004-05 (10)	FDA UDI	N/A	Unknown
HEp-2000® IgG Fluorescent ANA-Ro Test System	2420CS-Ro	FDA UDI	N/A	Active
Fluorescent ANA Test System	8145	FDA UDI	N/A	Active
Fluorescent ANA Test System	2280CS	FDA UDI	N/A	Active
HEp-2000® IgG Fluorescent ANA-Ro Test System	8202-Ro	FDA UDI	N/A	Active
HEp-2000® Fluorescent ANA-Ro Test System	2025 (2)	FDA UDI	N/A	Active
HEp-2000® IgG Fluorescent ANA-Ro Test System	8272.1-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.