We are pleased to announce that from today it will be possible to use Flu SensDx at home!
Our product has just received a medical device certificate for self-testing from PCBC. This means that a notified entity confirmed flu SensDx safety, ease of use, and reliability of the results with the no. 1434 given by the European Commission!
Flu SensDx detects influenza viruses even at a very early stage of infection. It is characterized by high sensitivity, comparable to the reference RT-PCR method. Moreover, the test is simple to use – the application guides the user step by step, which means that anyone can perform it. The test result is obtained within 5-7 minutes.
The whole project was handled by Dr. Sabina Żołędowska, our Quality and Certification Specialist, and her Compliance and Quality team. Dr. Sabina Żołędowska was responsible for the management of the whole certification process. It is also worth mentioning that Dr. Sabina Żołędowska is also accountable for ISO13485 certification for SensDx – the standard confirmed with no remarks since 2019 by TUV Rheinland. Thanks to her and her team, it will be possible to use Flu SensDx at your home.
What a great success!
Congratulations to all people involved.