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IMMUNO CONCEPTS INC

Last updated May 23, 2026

Information

Country: US
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FDA FEI Number: —
DUNS Number: 038271904

Catalogue (387)

Page 8 of 8

Device	Model / Reference	Registries	Class	Status
HEp-2000® IgG Fluorescent ANA-Ro Test System	8226-Ro	FDA UDI	N/A	Active
Cmv Igg Antibody Test (indirect Enzyme Test)	K893467	FDA 510(k)	Class II	Active
Cmv Igm Antibody Test (indirect Fluorescent Test)	K893465	FDA 510(k)	Class II	Active
Anti-Cardiolipin Antibody Test System	K911661	FDA 510(k)	Class II	Active
Sm-Rnp Autoantibody Test System	K860428	FDA 510(k)	Class II	Active
Ebv-Vca Igg Antibody Test System (enzyme)	K880885	FDA 510(k)	Class I	Active
Colorzyme Ebv Early Antigen Igg Antibody Test Sys	K912489	FDA 510(k)	Class I	Active
Relisa Mpo-Anca Test System For Antibodies To Myeloperoxidase, Model # 7096-15	K013285	FDA 510(k)	Class II	Active
Relisa Ena Antibody Screening Test System	K935129	FDA 510(k)	Class II	Active
Cmv Igm Antibody Test (indirect Enzyme Test)	K893466	FDA 510(k)	Class II	Active
Anti-Cardiolipin Antibody Screening Test System	K932225	FDA 510(k)	Class II	Active
Relsia Scl-70 Antibody Test System	K955602	FDA 510(k)	Class II	Active
Relisa Jo-1 Antibody Test System	K955605	FDA 510(k)	Class II	Active
Ebv-Vca Igm Antibody Test System (fluorescent)	K880886	FDA 510(k)	Class I	Active
Hep-2000 Fluorescent Ana-Ro Test System	K972145	FDA 510(k)	Class II	Active
Ebna Antibody Test System (immunofluorescent Anti)	K895708	FDA 510(k)	Class I	Active
Igg Anti-Ndna Fluorescent Test System; Model # 3040g	K013432	FDA 510(k)	Class II	Active
Hep-2000 Colorzyme Ana-Ro Test System, Model 4200-Ro	K983924	FDA 510(k)	Class II	Active
Colorzyme Ndna Test System	K843225	FDA 510(k)	Class II	Active
Relisa Ana Screening Test System, Model 7096-11	K992041	FDA 510(k)	Class II	Active
Crithidia Luciliae Native Dna-Ifa Test	K810301	FDA 510(k)	Class II	Active
Fluorecent Ebv-Early Antigen Igg Antibody Test Sys	K912488	FDA 510(k)	Class I	Active
Cmv Igg Antibody Test (indirect Fluorescent Test)	K893468	FDA 510(k)	Class II	Active
Immuno Concepts Anca Test Systems	K974478	FDA 510(k)	Class II	Active
Ana-Ifa Test System	K803276	FDA 510(k)	Class II	Active
Relisa Pr3-Anca Test System For Antibodies To Proteinase 3, Model # 7096-16	K013283	FDA 510(k)	Class II	Active
Enzyme Ana Test System	K833148	FDA 510(k)	Class II	Active
Ebv-Vca Igm Antibody Test System (enzyme)	K880884	FDA 510(k)	Class I	Active
Ss-A/Ss-B Autoantibody Test System	K860644	FDA 510(k)	Class II	Active
Ebna Antibody Test System (immunoenzyme Antibody)	K895707	FDA 510(k)	Class I	Active
Relisa Ena Single Well Screen Antibody Test System	K963275	FDA 510(k)	Class II	Active
Relisa Sm/Rnp Antibody Test System	K955604	FDA 510(k)	Class II	Active
Immuno Concepts Anca Test System	K974463	FDA 510(k)	Class II	Active
Hep-2000 Fluorescent Ana-Ro Test System	K944096	FDA 510(k)	Class II	Active
Relsia Ss-A/Ro & Ss/B La Antibody Test System	K955603	FDA 510(k)	Class II	Active
Hep-2000 Colorzyme Ana-Ro Test System	K950979	FDA 510(k)	Class II	Active
Ebv-Vca Igg Antibody Test System (fluorescent)	K880883	FDA 510(k)	Class I	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.