Remark "For research use only, not for diagnostic use“
The package inserts for all CANDOR solutions display the remark “For research use only, not for diagnostic use”. What is the reason for this remark and what are the consequences? The reason is based on legislation for human diagnostics. CANDOR only declares herewith that the solutions from CANDOR are not diagnostics. A diagnostic product such as an ELISA kit gives a measured value or a test result or in other words gives a “statement about a health parameter”. The solutions from CANDOR, e.g. LowCross-Buffer®, cannot give such a statement or result. They only support the process of generation of reliable test results, if they are part of a diagnostic kit. Due to this fact, the solutions from CANDOR themselves cannot be named as “diagnostics” and cannot be marked with a CE-mark. The remark “not for diagnostic use” is only a clarification about this situation. Nevertheless the solutions of CANDOR such as LowCross-Buffer® or HRP-ProtectorTM are routinely used for production of commercial diagnostics kits in human, veterinary, feed and food as well as environmental diagnostics. There is no restriction by CANDOR with respect to using the solutions for production of commercial kits. Any commercial kit manufacturer, who has purchased solutions from CANDOR for production, is allowed to use such solutions for production of their own kits without any restriction by CANDOR. The kit producers must ensure by themselves that the produced kits follow all legal rules such as IVD legislation, which may apply. The remark “not for diagnostic use” does not mean “not for production of diagnostic products”. The production of diagnostic products by using the CANDOR solutions is not restricted by CANDOR and it is done routinely by kit manufacturers worldwide.
If CANDOR solutions are purchased to use them for production of commercial kits, there is no need to get any kind of licence from CANDOR or to pay any royalties for a licence to CANDOR. The solutions are sold licence-free for production of commercial kits. No need for contracts, concessions, licences or anything like this. Buying the solution contains the right to use the solution for production of a commercial kit.