FDA Registration
Active
🇺🇸 United States
IMMCO DIAGNOSTICS, INC.
Reg #: 3015376545
·
FEI: 3015376545
·
Expires 2026
Products
19
Proprietary Names
25
Establishment Types
5
Classifications
19
Registration Details
- Registration Name
- IMMCO DIAGNOSTICS, INC.
- Registration Number
- 3015376545
- FEI Number
- 3015376545
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 10 Earhart Drive, --
- City
- Williamsville
- State
- NY
- ZIP
- 14221
- Country
- US
Regulatory Submissions
- 510(k) Number
- K172745
Owner / Operator
- Firm Name
- IMMCO DIAGNOSTICS, INC.
- Operator Number
- 1315336
- Address
- 10 EARHART DR., --
- City
- Buffalo
- State
- NY
- Postal Code
- 14221
- Country
- US
- Correspondent
- Lee Kroening
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Station, Pipetting And Diluting, For Clinical Use | JQW | Class 1 | Clinical Chemistry | No | 2016-03-04 |
| Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | DHN | Class 2 | Immunology | No | 2018-07-03 |
| Antinuclear Antibody, Antigen, Control | LKJ | Class 2 | Immunology | No | 2008-04-07 |
| Culture Media, Non-Propagating Transport | JSM | Class 1 | Microbiology | No | 2020-07-17 |
| Whole Human Serum, Antigen, Antiserum, Control | DGR | Class 1 | Immunology | No | 1992-07-08 |
| Microscope, Fluorescence/U.V. | IBK | Class 1 | Pathology | No | 2016-03-04 |
| System, Test, Rheumatoid Factor | DHR | Class 2 | Immunology | No | 2016-12-12 |
| Extractable Antinuclear Antibody, Antigen And Control | LLL | Class 2 | Immunology | No | 2016-12-12 |
| Anti-Sm Antibody, Antigen And Control | LKP | Class 2 | Immunology | No | 2016-12-12 |
| Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control | DBL | Class 2 | Immunology | No | 2008-04-07 |
| Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm) | MVJ | Class 2 | Immunology | No | 2019-06-24 |
| Reagent, Borrelia Serological Reagent | LSR | Class 2 | Microbiology | No | 2017-02-03 |
| Media, Mounting, Water Soluble | KEQ | Class 1 | Pathology | No | 1992-07-08 |
| Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control | LRM | Class 2 | Immunology | No | 2016-12-12 |
| Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | MOB | Class 2 | Immunology | No | 2016-12-12 |
| Autoantibodies, Endomysial(Tissue Transglutaminase) | MVM | Class 2 | Immunology | No | 2016-12-12 |
| Reagents, Specific, Analyte | MVU | Class 1 | Pathology | No | 2011-08-31 |
| Splint, Extremity, Non-Inflatable, External, Non-Sterile | NOC | Class 1 | General, Plastic Surgery | No | 2016-11-11 |
| Azan Counterstain | ICT | Class 1 | Hematology | No | 1992-07-08 |
Proprietary Names
Zenith ELITE
ImmuGlo HEp-2 ELITE IFA
Antinuclear Ab (Mouse Liver)
Bartels; Bartels Viral Trans
NEGATIVE CONTROL
iSight
ImmuLisa
Anti-Native DNA Antibody Test
Skin Ab (Monkey/Guinea Pig Esoph)
ImmuGlo Anti-GBM Antibody Kit
Lyme B. burgdorferi (IgG) MarStripe Test
Lyme B. burgdorferi (IgM) MarStripe Test
Antinuclear Ab Test (HEP-2 Cells)
Anti-Skin Ab (Monkey Esophaugus)
MOUNTING MEDIUM
Anti-Neutrophil Cytoplasmic ANCA Ab
Neuronal Antibody Strip
Neuronal Antibody Tissue Substrate
Hand Splint
Anti-Reticulin Antibody Test
EVANS BLUE COUNTERSTAIN
Anti-Endomysial Antibody (EMA) Test
Auto-Ab Test HEP-2/Mo. Kid/Stomach
Auto-Ab Mouse Kid/Stomach/Liver
Anti-Endomysial Antibody Test
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Repack or Relabel Medical Device
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Device in the United States for Export Only