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IMMUNO CONCEPTS INC

Last updated May 23, 2026

Information

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

Catalogue (387)

Page 4 of 8

Device	Model / Reference	Registries	Class	Status
Histofluor® Rodent LKS Fluorescent Antibody Test System	12021-02 (1)	FDA UDI	N/A	Active
HEp-2000® IgG Fluorescent ANA-Ro Test System	8283-Ro	FDA UDI	N/A	Active
HEp-2000® IgG Fluorescent ANA-Ro Test System	8247-Ro	FDA UDI	N/A	Active
HEp-2000® IgG Fluorescent ANA-Ro Test System	8198-Ro	FDA UDI	N/A	Active
IgG Anti-nDNA Fluorescent Test System	8287	FDA UDI	N/A	Active
HEp-2000® IgG Fluorescent ANA-Ro Test System	8294-Ro	FDA UDI	N/A	Active
HEp-2000® Fluorescent ANA-Ro Test System	2002-14-Ro	FDA UDI	N/A	Active
Histofluor® Rodent LKS Fluorescent Antibody Test System	12040-04R	FDA UDI	N/A	Unknown
HEp-2000® IgG Fluorescent ANA-Ro Test System	8315-Ro	FDA UDI	N/A	Active
HEp-2000® IgG Fluorescent ANA-Ro Test System	8320-Ro	FDA UDI	N/A	Active
HEp-2000® Fluorescent ANA-Ro Test System	8112-Ro	FDA UDI	N/A	Active
HEp-2000® Colorzyme® ANA-Ro Test System	4066 (5)	FDA UDI	N/A	Active
ANCA-L Test System	10140L-11	FDA UDI	N/A	Active
HEp-2000® IgG Fluorescent ANA-Ro Test System	2200CS-14-Ro	FDA UDI	N/A	Active
Immuno Concepts	1111C (4)	FDA UDI	N/A	Unknown
HEp-2000® Fluorescent ANA-Ro Test System	2023 (2)	FDA UDI	N/A	Active
Colorzyme® nDNA Test System	5005	FDA UDI	N/A	Active
Fluorescent ANA Test System	8323	FDA UDI	N/A	Active
AUTO I.D.® SSA/Ro and SSB/La Autoantibody Test System	7001 (1)	FDA UDI	N/A	Active
HEp-2000® Fluorescent ANA-Ro Test System	8400-Ro	FDA UDI	N/A	Active
HEp-2000® Colorzyme® ANA-Ro Test System	4200-14-Ro	FDA UDI	N/A	Active
Histofluor® Rodent LKS Fluorescent Antibody Test System	12160-03	FDA UDI	N/A	Active
IgG Anti-nDNA Fluorescent Test System	3001G	FDA UDI	N/A	Active
IgG Anti-nDNA Fluorescent Test System	3000G	FDA UDI	N/A	Active
Fluorescent ANA Test System	2200-14	FDA UDI	N/A	Active
Histofluor® Rodent LKS Fluorescent Antibody Test System	12009-02 (1)	FDA UDI	N/A	Active
Fluorescent nDNA Test System	8265.1	FDA UDI	N/A	Active
HEp-2000® Fluorescent ANA-Ro Test System	2000-14-Ro	FDA UDI	N/A	Active
HEp-2000® IgG Fluorescent ANA-Ro Test System	8400G-Ro	FDA UDI	N/A	Active
HEp-2000® IgG Fluorescent ANA-Ro Test System	8249-Ro	FDA UDI	N/A	Active
IgG Anti-nDNA Fluorescent Test System	8284	FDA UDI	N/A	Active
Fluorescent ANA Test System	1105 (4)	FDA UDI	N/A	Active
Fluorescent nDNA Test System	8268	FDA UDI	N/A	Active
ANCA Test System	10140-11(T)	FDA UDI	N/A	Active
HEp-2000® IgG Fluorescent ANA-Ro Test System	8206-Ro	FDA UDI	N/A	Active
ANCA Test System	10026-11 (2)	FDA UDI	N/A	Active
Histofluor® Rodent LKS Fluorescent Antibody Test System	12263-02 (1)	FDA UDI	N/A	Active
IgG Anti-nDNA Fluorescent Test System	3002G	FDA UDI	N/A	Active
HEp-2000® IgG Fluorescent ANA-Ro Test System	8279-Ro	FDA UDI	N/A	Active
Histofluor® Rodent LKS Fluorescent Antibody Test System	12400-02	FDA UDI	N/A	Unknown
Fluorescent ANA Test System	2040	FDA UDI	N/A	Active
RELISA® ANA Screening Test System	7696-11	FDA UDI	N/A	Active
Histofluor® Rodent LKS Fluorescent Antibody Test System	12040-03	FDA UDI	N/A	Active
ANCA Test System	10140-11	FDA UDI	N/A	Active
HEp-2000® Fluorescent ANA-Ro Test System	8300-Ro	FDA UDI	N/A	Active
HEp-2000® IgG Fluorescent ANA-Ro Test System	2140GCS-Ro	FDA UDI	N/A	Active
Histofluor® Rodent LKS Fluorescent Antibody Test System	12008-03 (10)	FDA UDI	N/A	Active
HEp-2000® IgG Fluorescent ANA-Ro Test System	8301-Ro	FDA UDI	N/A	Active
Fluorescent ANA Test System	2013 (20)	FDA UDI	N/A	Active
HEp-2000® Fluorescent ANA-Ro Test System	2021 (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.