- Model Name
- The most likely information available for a testkit/reagent or instrument platform is a model name (unofficial or official); usually when combined with the name of the manufacturer it is unique.
- Emergency Use Authorization Identifier
- Defines the particular combination of testkit/reagent(s) and instrument platform(s) is used that is authorized by an EUA as listed on the FDA website: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/vitro-diagnostics-euas#individual-molecular
- The combination of the value listed in the "Manufacturer" column and the value listed in the "Diagnostic (Letter of Authorization)" - including all spaces and special characters (except (TM) or (R)) creates the official name for this EUA
- a "+" at the end of the Diagnostic might indicate a significant update and consitutes a new entry in the table
- The goal is to provide that string in the CDC LIVD mapping file in the "Equipment UID" column, identifying the "Equipment UID Type" as EUA. e.g for the following EUA:
- COVID-19 Coronavirus Real Time PCR Kit Jiangsu Bioperfectus Technologies Co., Ltd.
- A smiliar identifier can be created for Lab Developed Tests (LDT) based on Appendix A table by combining "Laboratory" and "Letter Granting Inclusion under EUA", e.g. for the following
- Cormeum SARS-CoV-2 Assay_Cormeum Laboratory Services
- Device IdentifierIdentifier (AP: Question has arisen that for COVID-19, most EUA tests do NOT have UDIs. They do have GTINs as shown in data below. Thanks Riki! Do we wish to include GTIN where UDI is not available? )
- This must then be the device identifier according to the UDI definition by the FDA
- The manufacturer would have made this available, e.g. through their LIVD spreadsheet or otherwise and this likely would have been configured into the LIS so it need not be entered by a user at time of testing.