Skip to end of metadata
Go to start of metadata

You are viewing an old version of this page. View the current version.

Compare with Current Restore this Version View Page History

« Previous Version 3 Next »

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)

  • not EVERY result needs a Unique identifier