Source - RNS
RNS Number : 1893K
EKF Diagnostics Holdings PLC
09 April 2018
 

 

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 

 

 

 

Richard Evans, FD & COO

 

 

 

 

 

N+1 Singer (Nomad & Broker)

Tel: 020 7496 3000

Alex Price / Shaun Dobson

 

 

 

 

 

Walbrook PR Limited

Tel: 020 7933 8780 or [email protected]

Paul McManus / Lianne Cawthorne

Mob: 07980 541 893 / 07584 391 303

 


This information is provided by RNS
The company news service from the London Stock Exchange
 
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