IFU

IFU – Product Inserts

Capitainer sampling cards (B10, B50, SEP10 & DIP70) are CE-IVD (IVDR Class A) product registered according to the IVD Regulation (EU) 2017/746. The product is FDA registered as a IVD Class 1.

In other regions, where above registrations does not apply, the device is supplied as a research use only (RUO) product for research and non-diagnostic activities. End-users and laboratories are responsible for validating the assay results from Capitainer products.

Product availability may vary from country to country and is subject to varying regulatory requirements. Please contact your local sales representative for availability.