There is quite a bit of push back on this data element
Should support testkit and instrument device identifiers, in order to accommodate different patterns
Issues this data element is aiming to solve:
Linking instance data to LIDR entries
Identifying test kit issues for EUAs to better understand these new tests or in post market surveillance of 510k
Allowing to decide if results can be combined (harmonized methods)
What level of identification is needed:
manufacturer / model
device identifier of UDI
production identifier of UDI (serial number or lot number)
full UDI
Lab tests not covered by UDI
Lab developed tests (some of them may be coverable)
manual assessment of specimen (urin color / clarity, specimen characteristics (gradeing hemolysis, lipemia), grossing)