This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 (MAR).
EKF Diagnostics Holdings plc
("EKF", the "Company")
US FDA approval for Diaspect Tm
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.
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.
For more information on the DiaSpect Tm see: www.ekfdiagnostics.com/diaspect.html
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."
Enquiries:
EKF Diagnostics Holdings plc |
www.ekfdiagnostics.com |
Christopher Mills, Non-Executive Chairman |
Tel: 029 2071 0570 |
Julian Baines, CEO |
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Richard Evans, FD & COO |
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N+1 Singer (Nomad & Broker) |
Tel: 020 7496 3000 |
Alex Price / Shaun Dobson |
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Walbrook PR Limited |
Tel: 020 7933 8780 or [email protected] |
Paul McManus / Lianne Cawthorne |
Mob: 07980 541 893 / 07584 391 303 |
