Unipath, Ltd.
Country not established
- Devices
- 73
What Unipath, Ltd. makes
Unipath, Ltd. manufactures diagnostic tests and laboratory instruments, including home pregnancy tests (e.g., CLEARBLUE EASY and E.P.T. CERTAINTY), fertility monitors (CLEARPLAN EASY), and antimicrobial susceptibility test discs for identifying bacterial resistance (e.g., CEFEPINE, IMIPENEM). The company also produces hematology analyzers like the CELL-DYN 3000A for automated blood cell counting and biochemical assays, such as fibrinogen and serum albumin tests.
The portfolio includes devices regulated as Class I (e.g., pregnancy tests, susceptibility discs) and Class II (e.g., hematology analyzers, fertility monitors) under FDA 510(k) clearance. These products are listed in the FDA’s 510(k) registry, and the manufacturer is based in the United States.
Catalogue
Search and filter all 73 devicesShowing 1-50 of 73
Frequently asked questions
How many devices does Unipath, Ltd. have in the registry?
The registry currently lists 73 devices for Unipath, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Unipath, Ltd.'s devices?
Among its 50 most recently registered devices, Unipath, Ltd. has devices listed in FDA 510(k) (50 devices).
What risk classes do Unipath, Ltd.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Unipath, Ltd.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Unipath, Ltd. in the registry?
The most recently registered devices listed for Unipath, Ltd. include CLEARBLUE EASY, IMMUNOGLOBULINS G, CEFEPINE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC and TURBOX FIBRINOGEN.