US FDA clearance for Diaspect Tm

 9th Apr 2018

EKF Diagnostics Holdings plc (AIM: EKF), the AIM listed point-of-care business, announces US Food and Drug Administration 510(k) clearance and CLIA waiver by statute for the Company’s hand-held reagent-free hemoglobin analyzer, the DiaSpect Tm, approving the product for use in point of care and Certificate of Waiver settings.

 

DiaSpect-Tm-Hemoglobin-Analyzer

 

The DiaSpect Tm provides users with accurate hemoglobin measurements within two seconds of the microcuvette being placed into the analyzer. It is palm-sized, easy to transport and is battery operated for remote use.

 

Commenting, Julian Baines, CEO of EKF, said:

“The FDA approval of DiaSpect Tm is part of our overall strategy to widen the range of regulatory approvals for our existing product range and to drive sales growth for these products across additional geographies. The US market is a key target for our DiaSpect Tm product, where we see a significant need for an easy to use, accurate and portable hemoglobin measurement system that can deliver laboratory quality results to patients in the clinic within seconds.”

 

Read more about DiaSpect Tm

EKF Diagnostics Holdings plc
Christopher Mills, Non-Executive Chairman
Julian Baines, CEO
Richard Evans, FD and COO
00 44 29 2071 0570
 
N+1 Singer
Alex Price / Shaun Dobson
00 44 20 7496 3000

Walbrook PR Limited
Paul McManus
Lianne Cawthorne

00 44 20 7933 8780 or ekf@walbrookpr.com
00 44 7980 541 893
00 44 7584 391 303