Immuno Concepts, Inc.
Medical device manufacturer in Sacramento, CA.
36510(k) clearances
0PMA approvals
2recalls
Device types
- LLL Extractable Antinuclear Antibody, Antigen… 8
- DHN Antinuclear Antibody, Indirect… 7
- MOB Test System, Antineutrophil Cytoplasmic… 4
- LJM Antinuclear Antibody (Enzyme-Labeled)… 2
- GNP Antiserum, Cf, Epstein-Barr Virus 2
- LJN Antibody Igm, If, Epstein-Barr Virus 2
- LKQ Antibody Igm,If, Cytomegalovirus Virus 2
- LIN Antisera, Conjugated Fluorescent… 2
- LLM Test, Antigen, Nuclear, Epstein-Barr Virus 2
- LSE Epstein-Barr Virus, Other 2
- MID System, Test, Anticardiolipin Immunological 2
- KTL Anti-Dna Indirect Immunofluorescent Solid… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K013432 | Igg Anti-Ndna Fluorescent Test System; Model # 3040GKTL · Traditional | 11/29/2001SE |
| K013285 | Relisa Mpo-Anca Test System for Antibodies to Myeloperoxidase, Model # 7096-15MOB · Traditional | 11/14/2001SE |
| K013283 | Relisa PR3-ANCA Test System for Antibodies to Proteinase 3, Model # 7096-16MOB · Traditional | 11/14/2001SE |
| K992041 | Relisa Ana Screening Test System, Model 7096-11LJM · Traditional | 07/23/1999SE |
| K983924 | HEP-2000 Colorzyme Ana-Ro Test System, Model 4200-RODHN · Traditional | 12/18/1998SE |
| K972145 | HEP-2000 Fluorescent Ana-Ro Test SystemDHN · Traditional | 02/24/1998SE |
| K974478 | Immuno Concepts Anca Test SystemsMOB · Traditional | 02/09/1998SE |
| K974463 | Immuno Concepts Anca Test SystemMOB · Traditional | 02/09/1998SE |
| K963275 | Relisa Ena Single Well Screen Antibody Test SystemLLL · Traditional | 09/13/1996SE |
| K955605 | Relisa JO-1 Antibody Test SystemLLL · Traditional | 04/19/1996SE |
| K955604 | Relisa Sm/Rnp Antibody Test SystemLLL · Traditional | 04/19/1996SE |
| K955603 | Relsia Ss-A/Ro & Ss/B la Antibody Test SystemLLL · Traditional | 04/19/1996SE |
| K955602 | Relsia SCL-70 Antibody Test SystemLLL · Traditional | 04/19/1996SE |
| K950979 | HEP-2000 Colorzyme Ana-Ro Test SystemDHN · Traditional | 06/01/1995SE |
| K944096 | HEP-2000 Fluorescent Ana-Ro Test SystemDHN · Traditional | 11/21/1994SE |
| K935129 | Relisa Ena Antibody Screening Test SystemLLL · Traditional | 01/31/1994SE |
| K932225 | Anti-Cardiolipin Antibody Screening Test SystemMID · Traditional | 07/06/1993SE |
| K911661 | Anti-Cardiolipin Antibody Test SystemMID · Traditional | 12/09/1991SE |
| K912489 | Colorzyme Ebv Early Antigen Igg Antibody Test SysLSE · Traditional | 07/24/1991SE |
| K912488 | Fluorecent Ebv-Early Antigen Igg Antibody Test SysLSE · Traditional | 07/24/1991SE |
| K895708 | Ebna Antibody Test System (Immunofluorescent Anti)LLM · Traditional | 12/11/1989SE |
| K895707 | Ebna Antibody Test System (Immunoenzyme Antibody)LLM · Traditional | 12/08/1989SE |
| K893465 | CMV Igm Antibody Test (Indirect Fluorescent Test)LKQ · Traditional | 07/25/1989SE |
| K893468 | CMV Igg Antibody Test (Indirect Fluorescent Test)LIN · Traditional | 07/14/1989SE |
| K893467 | CMV Igg Antibody Test (Indirect Enzyme Test)LIN · Traditional | 07/14/1989SE |
| K893466 | CMV Igm Antibody Test (Indirect Enzyme Test)LKQ · Traditional | 07/14/1989SE |
| K880886 | Ebv-Vca Igm Antibody Test System (Fluorescent)LJN · Traditional | 08/30/1988SE |
| K880885 | Ebv-Vca Igg Antibody Test System (Enzyme)GNP · Traditional | 08/30/1988SE |
| K880884 | Ebv-Vca Igm Antibody Test System (Enzyme)LJN · Traditional | 08/30/1988SE |
| K880883 | Ebv-Vca Igg Antibody Test System (Fluorescent)GNP · Traditional | 08/30/1988SE |
| K860428 | Sm-Rnp Autoantibody Test SystemLLL · Traditional | 05/15/1986SE |
| K860644 | Ss-A/Ss-B Autoantibody Test SystemLLL · Traditional | 03/28/1986SE |
| K843225 | Colorzyme Ndna Test SystemDHN · Traditional | 11/01/1984SE |
| K833148 | Enzyme Ana Test SystemLJM · Traditional | 11/21/1983SE |
| K810301 | Crithidia Luciliae Native Dna-Ifa TestDHN · Traditional | 02/25/1981SE |
| K803276 | Ana-Ifa Test SystemDHN · Traditional | 01/26/1981SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1044-2009 | ANA Fluorescent Test System and ANA Colorzyme Test System, Sub assembly catalog number…Samples can occasionally run out of the wells and cross contaminate adjacent wells. | 12/04/2008Terminated |
| Z-1045-2009 | RELISA ENA Multiparameter Antibody Screening test, enzyme immunoassay test system…In certain patient samples, it is difficult to properly discriminate between anti-Sm/RMP positive samples… | 11/25/2008Terminated |