<status value="draft" /> <publisher value="NMDP" /> <contact> <name value="David Wroe" /> <telecom> <system value="email" /> <value value="fhir@nmdp.org" /> <use value="work" /> </telecom> </contact> <description value="# HLA Immunoassay Kit Extension of the HL7 Device resource Details about the assay kit used to create the results inlcuded in the referenced HLA Antibody Diagnostic Report ## Assay Kit Elements * **kit-manufacturer**: Company or institution that developed the kit * **kit-description** * **solid-phase-panel** * **catalog-number**: Identifier for the specific kit used * **lot-number**: Identifier for the lot used * **interpretation-software**: Software used for analysis * **interpretation-software-version**: Version of the software used * **Raw-MFI-divider**: Constant used for comparing multiple analysis machines * *Note*: Devices may have systematic biases on the same sample. This constant helps calibrate raw MFI across batches." /> <fhirVersion value="4.0.1" /> <kind value="resource" /> <abstract value="false" /> <type value="DeviceDefinition" /> <baseDefinition value="http://hl7.org/fhir/StructureDefinition/DeviceDefinition" /> <derivation value="constraint" /> <differential> <element id="DeviceDefinition.identifier"> <path value="DeviceDefinition.identifier" /> <min value="1" /> <max value="1" /> <mustSupport value="true" /> </element> <element id="DeviceDefinition.identifier.type.text"> <path value="DeviceDefinition.identifier.type.text" /> <mustSupport value="false" /> </element> <element id="DeviceDefinition.identifier.value"> <path value="DeviceDefinition.identifier.value" /> <min value="1" /> <mustSupport value="true" /> </element> <element id="DeviceDefinition.manufacturer"> <path value="DeviceDefinition.manufacturer" /> <mustSupport value="true" /> </element> <element id="DeviceDefinition.deviceName.name"> <path value="DeviceDefinition.deviceName.name" /> <short value="Solid Phase Immunoassay" /> <fixedString value="Solid Phase Immunoassay" /> <mustSupport value="true" /> </element> <element id="DeviceDefinition.deviceName.type"> <path value="DeviceDefinition.deviceName.type" /> <fixedCode value="manufacturer-name" /> </element> <element id="DeviceDefinition.modelNumber"> <path value="DeviceDefinition.modelNumber" /> <min value="1" /> <mustSupport value="true" /> </element> <element id="DeviceDefinition.version"> <path value="DeviceDefinition.version" /> <max value="1" /> <mustSupport value="true" /> </element> <element id="DeviceDefinition.safety"> <path value="DeviceDefinition.safety" /> <max value="0" /> </element> <element id="DeviceDefinition.shelfLifeStorage"> <path value="DeviceDefinition.shelfLifeStorage" /> <max value="0" /> </element> <element id="DeviceDefinition.property"> <path value="DeviceDefinition.property" /> <slicing> <discriminator> <type value="value" /> <path value="$this" /> </discriminator> <rules value="open" /> </slicing> </element> <element id="DeviceDefinition.property:interpretationSoftware"> <path value="DeviceDefinition.property" /> <sliceName value="interpretationSoftware" /> <max value="1" /> <mustSupport value="true" /> </element> <element id="DeviceDefinition.property:interpretationSoftware.type.coding"> <path value="DeviceDefinition.property.type.coding" /> <max value="0" /> </element> <element id="DeviceDefinition.property:interpretationSoftware.type.text"> <path value="DeviceDefinition.property.type.text" /> <label value="InterpretationSoftware" /> <short value="Interpretation software" /> <min value="1" /> </element> <element id="DeviceDefinition.property:interpretationSoftwareVersion"> <path value="DeviceDefinition.property" /> <sliceName value="interpretationSoftwareVersion" /> <max value="1" /> <mustSupport value="true" /> </element> <element id="DeviceDefinition.property:interpretationSoftwareVersion.type.text"> <path value="DeviceDefinition.property.type.text" /> <label value="InterpretationSoftwareVersion" /> <short value="Interpretation software version" /> <min value="1" /> </element> <element id="DeviceDefinition.property:lotNumber"> <path value="DeviceDefinition.property" /> <sliceName value="lotNumber" /> <max value="1" /> <mustSupport value="true" /> </element> <element id="DeviceDefinition.property:lotNumber.type.text"> <path value="DeviceDefinition.property.type.text" /> <label value="LotNumber" /> <short value="Lot number" /> <min value="1" /> </element> <element id="DeviceDefinition.contact"> <path value="DeviceDefinition.contact" /> <max value="0" /> </element> <element id="DeviceDefinition.material"> <path value="DeviceDefinition.material" /> <max value="0" /> </element> </differential> </StructureDefinition>