NorDiag today announced that the necessary clinical documentation for CE IVD labeling are in place and that the UL certification process has been completed, NorDiags Arrow instrument is therefore  available as a platform suitable for in vitro diagnostics (IVD) use in Europe. Clinical laboratories in Europe will now be able to use the instrument for clinical purposes.
 
"CE IVD (In Vitro Diagnostics) labeling is a growth driver and it enables sales to diagnostics laboratories and facilitates sales to several more customers", explains Mårten Wigstøl, CEO in NorDiag.

The Arrow instrument is a sample preparation tool that can be applied for testing of viruses, bacteria and transplantation diagnostics (HLA).

"This is a major milestone for us and we are now through all the regulatory hurdles for Arrow in the European market. NorDiag is offering two (and soon four) sample preparation kit variants to be used together with the instrument which are CE IVD marked. When we now enter the second quarter, we will have a strong product portfolio covering several applications for clinical laboratories which is a key element for successful sales of Arrows in the diagnostic market", Wigstøl comments.

NorDiags desk top and low throughput instrument Arrow has the capacity of up to 10 000 isolations per year. It has a very attractive price which enables many laboratories and hospitals to buy the instrument without a tender offering process.
 
Contact:   
CEO Mårten Wigstøl - Phone. +47 911 65775

Read the notice in Norwegian here.