FDA Registration
Active
🇺🇸 United States
IMMUNO CONCEPTS, NA, Ltd.
Reg #: 2918768
·
FEI: 2918768
·
Expires 2026
Products
13
Proprietary Names
35
Establishment Types
1
Classifications
13
Registration Details
- Registration Name
- IMMUNO CONCEPTS, NA, Ltd.
- Registration Number
- 2918768
- FEI Number
- 2918768
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 9825 Goethe Rd Ste 350
- City
- SACRAMENTO
- State
- CA
- ZIP
- 95827
- Country
- US
Regulatory Submissions
- 510(k) Number
- K912488
Owner / Operator
- Firm Name
- Immuno Concepts
- Operator Number
- 2918768
- Address
- 9825 Goethe Road, Suite 350
- City
- Sacramento
- State
- CA
- Postal Code
- 95827
- Country
- US
- Correspondent
- Nicole L Lasquete
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Epstein-Barr Virus, Other | LSE | Class 1 | Microbiology | No | 2007-12-22 |
| Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | MOB | Class 2 | Immunology | No | 2007-12-22 |
| Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | DHN | Class 2 | Immunology | No | 2007-12-22 |
| Antibody Igm, If, Epstein-Barr Virus | LJN | Class 1 | Microbiology | No | 2007-12-22 |
| Extractable Antinuclear Antibody, Antigen And Control | LLL | Class 2 | Immunology | No | 2007-12-22 |
| Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | LJM | Class 2 | Immunology | No | 2007-12-22 |
| Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use | PIV | Class 2 | Immunology | No | 2016-06-27 |
| System, Test, Anticardiolipin Immunological | MID | Class 2 | Immunology | No | 2007-12-22 |
| Test, Antigen, Nuclear, Epstein-Barr Virus | LLM | Class 1 | Microbiology | No | 2007-12-22 |
| Antiserum, Cf, Epstein-Barr Virus | GNP | Class 1 | Microbiology | No | 2007-12-22 |
| Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control | DBL | Class 2 | Immunology | No | 2019-09-23 |
| Antinuclear Antibody, Antigen, Control | LKJ | Class 2 | Immunology | No | 2007-12-22 |
| Anti-Dna Indirect Immunofluorescent Solid Phase | KTL | Class 2 | Immunology | No | 2007-12-22 |
Proprietary Names
EBV-EA Fluorescet
EBV-EA Colorzyme
RELISA PR3 ANCA
ANCA Ethanol Fluorescent
Colorzyme nDNA Test System
HEp-2000 Colorzyme (SSA Confirm)
HEP-2000 Fluorescent (SSA Confirm)
Fluorescent ANA Test System
EBV-VCA IgM Colorzyme
RELISA ENA Multiparameter
RELISA MPO ANCA
RELISA ANA Screening Test
AUTO ID Sm/RNP Autoantibody Test Sy
EBV-VCA IgM Fluorescent
AUTO ID SSA/SSB Autoantibody System
RELISA Jo-1
Image Navigator by Immuno Concepts
RELISA Cardiolipin IgG & IgM Test
HEp-2000 Fluorescent ANA-Ro
EBNA Fluorescent
EBV-VCA IgG Colorzyme
Histofluor® Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno Concepts
RELISA Scl-70
RELISA Cardiolipin Antibody Screen
AUTO ID Optional Controls
RELISA SSA/SSB
IgG Anti-nDNA Fluorescent Test
RELISA ENA Single Well Screen
Colorzyme ANA Test System
HEp-2000 Colorzyme ANA-Ro
Fluorescent nDNA Test System
ANCA Formalin Fluorescent
EBNA Colorzyme
EBV-VCA IgG Fluorescent
RELISA Sm/RNP
Establishment Types
Manufacture Medical Device