NEW YORK (360Dx) – Beckman Coulter said today that it has received US Food and Drug Administration 510(k) clearance for its Navios EX flow cytometer.
The Navios allows for simultaneous measurement of up to 12 parameters in individual cells. Beckman Coulter is launching the instrument at the American Association for Clinical Chemistry's annual meeting in San Diego this week.
"The Navios EX provides a standardized and fast solution for advanced flow cytometry applications requiring quality, reproducibility, and sensitivity,” Mario Koksch, vice president and general manager of Beckman Coulter’s cytometry business unit, said in a statement. "This makes it especially valuable for use, for example, in clinical trials or other highly regulated events where multi-site comparable results are essential."
Beckman Coulter also highlighted this week its FDA-cleared ClearLLab reagents — antibody cocktails for clinical flow cytometry-based leukemia and lymphoma immunophenotyping. According to the company, the preformulated reagents allow clinical labs to avoid manual preparation of in-house antibody cocktails, streamlining sample prep and improving reliability of results.