Coulter Immunology
Country not established
- Devices
- 14
What Coulter Immunology makes
The company produces monoclonal antibodies and immunofluorescence reagents, including COULTERCLONE T-cell and B-cell markers (e.g., T1, T3, T4, T8, B4), polyclonal anti-immunoglobulin antibodies (e.g., GAM-FITC for IgG/IgM), and whole-blood staining kits (e.g., QUICK STAIN WHOLE BLOOD LYSE-II). It also supplies conjugated antibody reagents like CYTO-STAT/COULTER CLONE T11-RD1/B4-FITC for flow cytometry applications.
These products fall under FDA-regulated Class I and Class II devices, with most requiring 510(k) clearance. The company’s portfolio is listed in the FDA’s 510(k) database, and the manufacturer is based in the United States.
Catalogue
Search and filter all 14 devicesFrequently asked questions
How many devices does Coulter Immunology have in the registry?
The registry currently lists 14 devices for Coulter Immunology. Devices recorded under merged duplicate company entries are counted once.
Which registries list Coulter Immunology's devices?
Among its 14 most recently registered devices, Coulter Immunology has devices listed in FDA 510(k) (14 devices).
What risk classes do Coulter Immunology's devices fall under?
Among its 14 most recently registered devices, the classes recorded for Coulter Immunology's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Coulter Immunology in the registry?
The most recently registered devices listed for Coulter Immunology include CYTO-STAT/COULTER CLONE T4-RD1/T8-FITC MONO ANTI, CYTO-STAT/COULTER CLONE T11-RD1/B1-FITC MONO. ANTI, COULTER CLONE MO2 and COULTERCLONE.