Labeling IVD Class III



Can you put an IVD Labeled component in an IUO test kit?
- We use an approved component which has an IVD label inside our IUO collection test kit

I would assume we can as long as the IVD label is appropriate and correct and the IUO has its properly labeling correct? If were creating new assay test that use other components manufactured and approved by other companies (therefore labeled with IVD), we need to pack them inside our IUO, this should be okay?

Thank you group!!!
Top Bottom