The IVD directive encompasses requirements regarding safety, performance and function. The quality assurance of Calmark's product COVID19-LDH, for assessment of disease severity, is now successfully completed in all these regards.
In addition to giving Calmark authorization to sell the product within the EU, the CE Mark further opens up opportunities for accelerated registration on other markets, which have special regulations for COVID-19 products.
”It is with deep satisfaction that we announce the CE conformity marking of our product COVID19-LDH,” says Anna Söderlund, CEO. "When the pandemic struck, we reorganized the company to develop a point-of-care LDH-test adapted for covid-19 in record time on the same platform as the products for newborns. I would like to extend my gratitude to my fabulous team for their competence and the massive effort they have invested in this product."
Calmark POC - Covid is a platform that consists of an instrument, a related software and a single-use test cassette, intended for the biomarker lactate dehydrogenase (LDH). The platform can be used on e.g. emergency rooms and wards in hospitals. Calmark has several distributor agreements regarding the product, including with the company P.R.I.S.M.A. Srl in Italy, where the agreement covers a minimum volume of SEK 4.6 million.
This information is information that Calmark Sweden AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, on 15 April 2021, xx:xx CET.
Every care has been taken in the translation of this document. In the event of discrepancies, the Swedish original will supersede the English translation.