Quality Assurance

Regulatory information

AroCell is developing, manufacturing, and distributing in vitro diagnostic products regulated under the IVD directive of the European Union. AroCells products TK 210 ELISA are CE-marked and registered as in vitro diagnostic medical devices at the Swedish Medical Products Agency (MPA), the Swedish Competent Authority responsible for market surveillance related to the law on medical devices.

AroCells subsidiary, IDL Biotech, is manufacturing and distributing UBC® Rapid, TUBEX® TF, and TUBEX® TF Wash. In addition, TPS® ELISA is also manufactured but only for distribution in China. IDL Biotech’s other ELISA/IRMA products, MonoTotal®, TPS®, TPAcyk™, and UBC are out-licensed and are manufactured and distributed by Beckman Coulter.

TUBEX®, TPS® , UBC® , MonoTotal® and TPAcyk™ are trademarks of IDL Biotech.

IDL Biotech meets high quality standards, and all of the products are developed, manufactured, and supplied to the market according to EN ISO 13485:2016 standardized procedures, and CE marked in accordance with the European IVD directive. 


We are listed on NASDAQ First North Growth Market.

We want to be the obvious choice within our segment in the markets where we are established. The market for our products is large and we are a smaller player with significant growth potential so far. AroCell is unique for a company of this size.