EKF Diagnostics Holdings PLC US FDA approval for Diaspect Tm (1893K)
April 09 2018 - 3:25AM
UK Regulatory
TIDMEKF
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 ekf@walbrookpr.com
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
END
REAUWVSRWNASRAR
(END) Dow Jones Newswires
April 09, 2018 03:25 ET (07:25 GMT)
Ekf Diagnostics (LSE:EKF)
Historical Stock Chart
From Aug 2024 to Sep 2024
Ekf Diagnostics (LSE:EKF)
Historical Stock Chart
From Sep 2023 to Sep 2024