Attana completes FDA Medical Device Class 1 listing and facility registration
Attana is pleased to announce today that it has completed a Medical Device listing of Attana Cell™ 250 and a facility registration of Attana, with the U.S. Food and Drug Administration (FDA).
The facility registration and listing of Attana Cell™ 250 as a Class I device (510(k) exempt) are the first regulatory requirements for marketing Attana’s instruments towards the clinical diagnostics market. In 2021, Attana intends to complement these by filing for an FDA approval of at least one complementary assay as a Class II device, subject to 510(k) clearance. Simultaneous to these efforts, Attana will evaluate the possibility of completing a similar regulatory process with the European Medicines Agency (EMA).
For more information, please contact:
Niklas Carlsson, COO
niklas.carlsson@attana.com
+46 (0)73 867 67 62
The Board of directors for Attana consider that the information in this press release is not likely to have a significant effect on the share price but is of general interest for the shareholders and hence should be communicated.
About Attana
Attana was founded in 2002 with the vision of in-vitro characterization of molecular interactions mimicking in-vivo conditions. Since then, Attana has developed proprietary label free biosensors for biochemical, crude, sera, and cell-based assays and the Attana Virus Analytics (AVA) platform, a proprietary in-vitro diagnostics (IVD) tool. Attana products and research services are used by Big Pharma, biotech companies and academic institutions within the life sciences. To learn more about our latest services and products, please visit www.attana.se or contact sales@attana.com.
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