Immunology device contract manufacturers
28 US facilities list immunology devices with FDA as a contract manufacturer (24) or contract sterilizer (4), across 58 FDA product codes in the Immunology classification panel.
FDA-registered (openFDA, export of Oct 21, 2026)
Most-listed immunology device types
| Product code | Device (FDA name) | Class | Facilities |
|---|
Where they are
Top states by registered address.
| State | Facilities |
|---|---|
| California | 8 |
| Illinois | 4 |
| Minnesota | 3 |
| New Jersey | 2 |
| Pennsylvania | 2 |
| Missouri | 1 |
| Mississippi | 1 |
| New York | 1 |
| Ohio | 1 |
| Puerto Rico | 1 |
Device classes listed
Facilities listing at least one immunology device of each FDA class.
| Class | Facilities |
|---|---|
| Class II | 25 |
| Class I | 6 |
| Not classified | 1 |
All 28 facilities
| Company | FDA registration | Establishment type | Immunology devices listed | City and state | Certification | Updated |
|---|---|---|---|---|---|---|
| ARLINGTON SCIENTIFIC, INC. | 1641328 | Contract manufacturer | System, Test, Rheumatoid Factor; System, Test, Infectious Mononucleosis +1 more | Springville, UT | Not verified | Oct 21, 2026 |
| BECKMAN COULTER, INC. | 2050010 | Contract manufacturer | System, Test, Rheumatoid Factor; Complement C4, Antigen, Antiserum, Control +26 more | Carlsbad, CA | Not verified | Oct 21, 2026 |
| BECKMAN COULTER, INC. | 2122870 | Contract manufacturer | System, Test, Thyroid Autoantibody | Chaska, MN | Not verified | Oct 21, 2026 |
| BIO-RAD LABORATORIES, INC. | 3032705 | Contract manufacturer | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control; System, Test, Infectious Mononucleosis +8 more | Woodinville, WA | Not verified | Oct 21, 2026 |
| BION ENTERPRISES, LTD. | 1419968 | Contract manufacturer | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | Des Plaines, IL | Not verified | Oct 21, 2026 |
| Becton Dickinson Caribe, LTD | 3008352382 | Contract manufacturer | Cytokeratins | Cayey, PR | Not verified | Oct 21, 2026 |
| CALBIOTECH, INC. | 2090110 | Contract manufacturer | System, Test, Thyroid Autoantibody; Extractable Antinuclear Antibody, Antigen And Control | El Cajon, CA | Not verified | Oct 21, 2026 |
| CENOGENICS CORP. | 2250030 | Contract manufacturer | System, Test, Rheumatoid Factor; System, Test, C-Reactive Protein | Morganville, NJ | Not verified | Oct 21, 2026 |
| CLINIQA CORPORATION | 2085064 | Contract manufacturer | Brain Trauma Assessment Test | San Marcos, CA | Not verified | Oct 21, 2026 |
| CURRIER PLASTICS | 1319436 | Contract manufacturer | Radioimmunoassay, Immunoglobulins (G, A, M) | Auburn, NY | Not verified | Oct 21, 2026 |
| DIASORIN INC. | 2182595 | Contract manufacturer | Transferrin, Antigen, Antiserum, Control; Albumin, Antigen, Antiserum, Control | Stillwater, MN | Not verified | Oct 21, 2026 |
| EUROIMMUN US INC. | 3007118747 | Contract manufacturer | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control; Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use | Mountain Lakes, NJ | Not verified | Oct 21, 2026 |
| Fisher Diagnostics | 1181121 | Contract manufacturer | System, Test, Rheumatoid Factor; Complement C4, Antigen, Antiserum, Control +11 more | Middletown, VA | Not verified | Oct 21, 2026 |
| Fujirebio Diagnostics, Inc. | 2521625 | Contract manufacturer | Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers; Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) +3 more | Malvern, PA | Not verified | Oct 21, 2026 |
| HARWOOD DESIGN, INC. | 3003761012 | Contract manufacturer | Prealbumin, Fitc, Antigen, Antiserum, Control | Bristol, PA | Not verified | Oct 21, 2026 |
| INOVA DIAGNOSTICS, INC. | 2026994 | Contract manufacturer | System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) | San Diego, CA | Not verified | Oct 21, 2026 |
| IVD RESEARCH, LLC. | 2031468 | Contract manufacturer | Lactoferrin, Antigen, Antiserum, Control | Carlsbad, CA | Not verified | Oct 21, 2026 |
| Isomedix Operations, Inc. | 1424263 | Contract sterilizer | Whole Human Serum, Antigen, Antiserum, Control | Libertyville, IL | Not verified | Oct 21, 2026 |
| Millstone Medical Outsourcing LLC | 3010097171 | Contract manufacturer | Complement C4, Antigen, Antiserum, Control | Olive Branch, MS | Not verified | Oct 21, 2026 |
| Planet Innovation Products, Inc. | 2022994 | Contract manufacturer | System, Test, Radioallergosorbent (Rast) Immunological | Irvine, CA | Not verified | Oct 21, 2026 |
| QUALITY TECH SERVICES, LLC | 3003477135 | Contract manufacturer | System, Test, Radioallergosorbent (Rast) Immunological | Bloomington, MN | Not verified | Oct 21, 2026 |
| RPI BIOSOLUTIONS | 3025663244 | Contract manufacturer | Trichomonas Vaginalis Nucleic Acid Amplification Test System | Mundelein, IL | Not verified | Oct 21, 2026 |
| SIGMA-ALDRICH MANUFACTURING, LLC | 1938173 | Contract manufacturer | System, Immunomagnetic, Circulating Cancer Cell, Enumeration | St. Louis, MO | Not verified | Oct 21, 2026 |
| SPARTRONICS STRONGSVILLE, INC. | 3003144120 | Contract manufacturer | System, Immunomagnetic, Circulating Cancer Cell, Enumeration | Strongsville, OH | Not verified | Oct 21, 2026 |
| Sekisui Diagnostics, LLC | 2030538 | Contract manufacturer | System, Test, Infectious Mononucleosis | San Diego, CA | Not verified | Oct 21, 2026 |
| Sterigenics U.S., LLC | 2029275 | Contract sterilizer | System, Test, Radioallergosorbent (Rast) Immunological; Ige, Antigen, Antiserum, Control | Corona, CA | Not verified | Oct 21, 2026 |
| Sterigenics US LLC | 1423662 | Contract sterilizer | System, Test, Radioallergosorbent (Rast) Immunological; Plates And Equipment, Radial Immunodiffusion | Gurnee, IL | Not verified | Oct 21, 2026 |
| Sterigenics US LLC | 1649518 | Contract sterilizer | Lambda, Antigen, Antiserum, Control; Kappa, Antigen, Antiserum, Control | Fort Worth, TX | Not verified | Oct 21, 2026 |