Unilife has received US Food and Drug Administration (FDA) 510(k) market clearance for Unitract Tuberculin (TB) Syringe.
Unilife said that Unitract TB syringe is different from Unitract 1ml Insulin Syringe for which it secured FDA clearance earlier this year.
Unilife claims that with Unitract range of 1ml syringes operators can easily control the speed of passive (automatic) needle retraction directly from the patient’s body into the barrel of the syringe where it is locked in place.
Unilife CEO Alan Shortall said that FDA 510(k) market clearance for Unitract TB syringe marks an important step in the company’s efforts to bring a complete line of safety syringes to market, as it is their second product to receive this clearance.
“With TB syringes most commonly used within acute-care hospitals and other healthcare facilities, FDA clearance of our Unitract TB syringe significantly broadens our capacity to market our unique products across the US and other key international markets,” Shortall said.