FDA Approves Biopool Kit to Gauge Enzyme in Blood
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Biopool International Inc. of Ventura has received Food and Drug Administration approval to market a kit that determines the level of a clot-dissolving enzyme in blood.
The Chromolize tPA Assay Kit, which measures tissue plasminogen activator (tPA) in blood, is the third Biopool product to receive FDA approval this year.
Tissue plasminogen activator is a major enzyme involved in the dissolution of blood clots. Though the formation of a clot is a normal response to vascular injury, intravascular clots can be life-threatening.
Earlier this year, the company received FDA approval to market two other test kits designed to help diagnose and prevent cardiovascular disease.
Biopool International develops and manufactures kits to assess and diagnose blood and vascular disorders, as well as tests to monitor and measure the presence of drugs.
The company’s products are sold to hospitals and laboratories.
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