IMMUNO CONCEPTS, NA, Ltd.
Sacramento, CA, US
IMMUNO CONCEPTS, NA, Ltd. appears in FDA device records in Sacramento, CA. FDA records list 40 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to IMMUNO CONCEPTS, NA, Ltd. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Immuno Concepts, Inc.510(k), recall
510(k) clearance history
FDA records hold 40 510(k) clearances for IMMUNO CONCEPTS, NA, Ltd. between 1981 and 2023. The busiest year on record is 1989, with 6. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1981 | 2 |
| 1983 | 1 |
| 1984 | 1 |
| 1986 | 2 |
| 1988 | 4 |
| 1989 | 6 |
| 1991 | 3 |
| 1993 | 1 |
| 1994 | 2 |
| 1995 | 1 |
| 1996 | 5 |
| 1998 | 4 |
| 1999 | 1 |
| 2001 | 3 |
| 2003 | 1 |
| 2016 | 1 |
| 2018 | 1 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K203599 | Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test System | KTL | Substantially Equivalent | |
| K180202 | Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno Concepts | DBL | Substantially Equivalent | |
| K160265 | Image Navigator by Immuno Concepts | DHN | Substantially Equivalent | |
| K030775 | AUTO I.D. JO-1, SCL-70 & PCNA POSITIVE CONTROL SERUM | LKJ | Substantially Equivalent | |
| K013432 | IGG ANTI-NDNA FLUORESCENT TEST SYSTEM; MODEL # 3040G | KTL | Substantially Equivalent | |
| K013285 | RELISA MPO-ANCA TEST SYSTEM FOR ANTIBODIES TO MYELOPEROXIDASE, MODEL # 7096-15 | MOB | Substantially Equivalent | |
| K013283 | RELISA PR3-ANCA TEST SYSTEM FOR ANTIBODIES TO PROTEINASE 3, MODEL # 7096-16 | MOB | Substantially Equivalent | |
| K992041 | RELISA ANA SCREENING TEST SYSTEM, MODEL 7096-11 | LJM | Substantially Equivalent | |
| K983924 | HEP-2000 COLORZYME ANA-RO TEST SYSTEM, MODEL 4200-RO | DHN | Substantially Equivalent | |
| K972145 | HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM | DHN | Substantially Equivalent | |
| K974478 | IMMUNO CONCEPTS ANCA TEST SYSTEMS | MOB | Substantially Equivalent | |
| K974463 | IMMUNO CONCEPTS ANCA TEST SYSTEM | MOB | Substantially Equivalent | |
| K963275 | RELISA ENA SINGLE WELL SCREEN ANTIBODY TEST SYSTEM | LLL | Substantially Equivalent | |
| K955605 | RELISA JO-1 ANTIBODY TEST SYSTEM | LLL | Substantially Equivalent | |
| K955604 | RELISA SM/RNP ANTIBODY TEST SYSTEM | LLL | Substantially Equivalent | |
| K955603 | RELSIA SS-A/RO & SS/B LA ANTIBODY TEST SYSTEM | LLL | Substantially Equivalent | |
| K955602 | RELSIA SCL-70 ANTIBODY TEST SYSTEM | LLL | Substantially Equivalent | |
| K950979 | HEP-2000 COLORZYME ANA-RO TEST SYSTEM | DHN | Substantially Equivalent | |
| K944096 | HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM | DHN | Substantially Equivalent | |
| K935129 | RELISA ENA ANTIBODY SCREENING TEST SYSTEM | LLL | Substantially Equivalent | |
| K932225 | ANTI-CARDIOLIPIN ANTIBODY SCREENING TEST SYSTEM | MID | Substantially Equivalent | |
| K911661 | ANTI-CARDIOLIPIN ANTIBODY TEST SYSTEM | MID | Substantially Equivalent | |
| K912489 | COLORZYME EBV EARLY ANTIGEN IGG ANTIBODY TEST SYS | LSE | Substantially Equivalent | |
| K912488 | FLUORECENT EBV-EARLY ANTIGEN IGG ANTIBODY TEST SYS | LSE | Substantially Equivalent | |
| K895708 | EBNA ANTIBODY TEST SYSTEM (IMMUNOFLUORESCENT ANTI) | LLM | Substantially Equivalent | |
| K895707 | EBNA ANTIBODY TEST SYSTEM (IMMUNOENZYME ANTIBODY) | LLM | Substantially Equivalent | |
| K893465 | CMV IGM ANTIBODY TEST (INDIRECT FLUORESCENT TEST) | LKQ | Substantially Equivalent | |
| K893468 | CMV IGG ANTIBODY TEST (INDIRECT FLUORESCENT TEST) | LIN | Substantially Equivalent | |
| K893467 | CMV IGG ANTIBODY TEST (INDIRECT ENZYME TEST) | LIN | Substantially Equivalent | |
| K893466 | CMV IGM ANTIBODY TEST (INDIRECT ENZYME TEST) | LKQ | Substantially Equivalent | |
| K880886 | EBV-VCA IGM ANTIBODY TEST SYSTEM (FLUORESCENT) | LJN | Substantially Equivalent | |
| K880885 | EBV-VCA IGG ANTIBODY TEST SYSTEM (ENZYME) | GNP | Substantially Equivalent | |
| K880884 | EBV-VCA IGM ANTIBODY TEST SYSTEM (ENZYME) | LJN | Substantially Equivalent | |
| K880883 | EBV-VCA IGG ANTIBODY TEST SYSTEM (FLUORESCENT) | GNP | Substantially Equivalent | |
| K860428 | SM-RNP AUTOANTIBODY TEST SYSTEM | LLL | Substantially Equivalent | |
| K860644 | SS-A/SS-B AUTOANTIBODY TEST SYSTEM | LLL | Substantially Equivalent | |
| K843225 | COLORZYME NDNA TEST SYSTEM | DHN | Substantially Equivalent | |
| K833148 | ENZYME ANA TEST SYSTEM | LJM | Substantially Equivalent | |
| K810301 | CRITHIDIA LUCILIAE NATIVE DNA-IFA TEST | DHN | Substantially Equivalent | |
| K803276 | ANA-IFA TEST SYSTEM | DHN | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2918768 | 2918768 | IMMUNO CONCEPTS, NA, Ltd. | 9825 Goethe Rd Ste 350, SACRAMENTO, CA 95827 US | 2026 | and 3 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KTLAnti-Dna Indirect Immunofluorescent Solid Phase
- LJNAntibody Igm, If, Epstein-Barr Virus
- LKQAntibody Igm,If, Cytomegalovirus Virus
- LJMAntinuclear Antibody (Enzyme-Labeled), Antigen, Controls
- LKJAntinuclear Antibody, Antigen, Control
- DHNAntinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
- LINAntisera, Conjugated Fluorescent, Cytomegalovirus
- GNPAntiserum, Cf, Epstein-Barr Virus
- PIVAutomated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use
- LSEEpstein-Barr Virus, Other
- LLLExtractable Antinuclear Antibody, Antigen And Control
- DBLMultiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
- MIDSystem, Test, Anticardiolipin Immunological
- MOBTest System, Antineutrophil Cytoplasmic Antibodies (Anca)
- LLMTest, Antigen, Nuclear, Epstein-Barr Virus
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1044-2009 | ANA Fluorescent Test System and ANA Colorzyme Test System, Sub assembly catalog number SA 2013, Kit Catalog Numbers, 2000, 2002, 2003, 2004, 2005, 2100, 2200, 4000, 4200, 8024.1, and 8060, manufactured by Immuno Concepts N.A. Ltd, Sacramento, CA. The device is used in the screening and titration of circulating antinuclear antibodies by means of an immunofluoresence test. Products are to be used as an aid in the detection of antibodies associated with systemic rheumatic disease. | Samples can occasionally run out of the wells and cross contaminate adjacent wells. | Terminated | ||
| Z-1045-2009 | RELISA ENA Multiparameter Antibody Screening test, enzyme immunoassay test system, manufactured by Immuno Concepts N.A. Ltd., Sacramento, CA. | In certain patient samples, it is difficult to properly discriminate between anti-Sm/RMP positive samples and samples that are only anti-Sm positive. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain