Hi..
Another interesting question I have is as below:
We are manufacturing an empty calibration plate (that will have 48wells, 96wells, etc..). We would like to sell these empty hard shell plates to both RUO and IVD customers. The customers will then add their own chemistry and perform calibration of the instruments. These plates are sold separately, NOT as part of the instrument system.
As no chemistry inside, the "General Purpose Reagent" label is not applicable.
If I label as "For in vitro diagnostic use only or IVD symbol", I can sell it for both RUO and IVD purposes. However, I need to list as Class I medical device with FDA and the controls are more.
So in this regard, if I label them as "For laboratory Use" or "General Purpose Laboratory Equipment" can I then sell for both RUO and IVD purposes, so that the listing with US FDA may still requires, but the controls are less (label and complaint MDR files) when compared to listing the device as Class I (Complete QSR).
Thanks,
Sreenu