Hemcheck Sweden AB has today submitted all required documentation to the Swedish Medical Products Agency, to extend the CE mark regarding hemolysis tests in vacuum tubes, the v-Test, to include so-called serum tubes.
Serum tubes is a common type of vacuum tube containing a coagulation activator to accelerate the coagulation of the blood. Hemcheck Sweden AB’s v-Test was previously approved for vacuum tubes of types EDTA, Lithium Heparin and Citrate, but will now also be approved for serum tubes (except for tubes containing a thrombin additive).
– Several customers using serum tubes have shown interest in testing our solution. Therefore, we have in parallel with the ongoing sales efforts, performed technical evaluation and user tests, together with the regulatory work required to update the CE marking to include serum tubes. As a result, our potential market will become larger and we now have plans to perform tests with customers using serum tubes, says Joen Averstad, CEO of Hemcheck.
For further information, contact:
Hemcheck Sweden AB (publ)
Joen Averstad, CEO
Tel: +46 076 108 8191
Hemcheck Sweden AB, founded in 2010, produces and commercializes a patented CE-marked concept for point of care hemolysis detection. The concept consists of disposable tests as well as readers that can very quickly, directly upon sampling, identify hemolysed blood samples in vacuum tubes and blood gas syringes. Hemolysis, ruptured red blood cells, is the most common reason globally why blood samples cannot be analyzed accurately. Hemcheck’s goal is to contribute to improved healthcare by offering user-friendly services for the detection of hemolysed blood samples in direct connection with blood sampling. By doing so, Hemcheck can contribute to increased patient safety, more efficient processes and lower costs. The company is based in Karlstad and is listed on the Nasdaq First North Growth Market.
FNCA Sweden AB, 08-528 00 399 info@fnca, is a Certified Adviser to the company.