Coulter Corp.
United StatesFDA applicant, unverified
- Devices
- 49
What Coulter Corp. makes
Coulter Corp. manufactures laboratory reagents and hematology analyzers, including urea nitrogen and carbon dioxide reagents, alkaline phosphatase (ALP) reagents, and monoclonal antibody reagents for immune cell analysis. Their portfolio also includes automated blood cell counters like the AC.T Series and Z1 analyzers, as well as sample preparation systems such as the Multi Q Prep and cell control standards like the 4C Plus. These products are designed for clinical chemistry and hematology testing in diagnostic laboratories.
The company’s devices are regulated under FDA’s 510(k) pathway, with products classified as Class I and Class II medical devices. Reagents and analyzers are listed in the FDA’s 510(k) database, reflecting their compliance with U.S. regulatory requirements. Coulter Corp. operates from the United States.
Catalogue
Search and filter all 49 devicesFrequently asked questions
How many devices does Coulter Corp. have in the registry?
The registry currently lists 49 devices for Coulter Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Coulter Corp.'s devices?
Among its 49 most recently registered devices, Coulter Corp. has devices listed in FDA 510(k) (49 devices).
What risk classes do Coulter Corp.'s devices fall under?
Among its 49 most recently registered devices, the classes recorded for Coulter Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Coulter Corp. in the registry?
The most recently registered devices listed for Coulter Corp. include COULTER ALBUMIN REAGENT, COULTER CK (CREATINE KINASE) REAGENT, COULTER HDL - CHOLESTEROL REAGENT and COULTER TOTAL BILIRUBIN REAGENT.