Hemoglobin A2

Trinity Biotech Announces That It Has Received 510(k) Clearance From The U.S. Food and Drug Administration for the Premier Resolution System

Retrieved on: 
Monday, August 7, 2023
Hemoglobin A2, IEX, Trinity, Sickle cell disease, Food and Drug Administration, Sale, Incidence, Fetal hemoglobin, Laboratory, Thalassemia, FDA, Food, HPLC, Software, Medical device, A2

DUBLIN, Ireland, Aug. 07, 2023 (GLOBE NEWSWIRE) -- Trinity Biotech has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Premier Resolution System, an automated analyzer for the accurate & precise quantification of hemoglobins F and A2, and the detection of >200 hemoglobin variants.

Key Points: 
  • DUBLIN, Ireland, Aug. 07, 2023 (GLOBE NEWSWIRE) -- Trinity Biotech has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Premier Resolution System, an automated analyzer for the accurate & precise quantification of hemoglobins F and A2, and the detection of >200 hemoglobin variants.
  • The Premier Resolution System is now cleared for sale in the United States.
  • The Premier Resolution System is a modern successor to Trinity Biotech’s Ultra System that held a leading position in the US hemoglobin variant diagnostic market.
  • The Premier Resolution gives laboratories the tools to easily identify clinically important variants.