Unipath, Ltd.

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.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.