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# Guide on IVD Codes for eHealth Records
- URL: https://www.fdaweb.com/guide-on-ivd-codes-for-ehealth-records/
- Published: 2018-06-15T12:00:00.000Z
- Updated: 2026-09-15T00:13:31.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5141700

FDA has posted a guidance on “Logical Observation Identifiers Names and Codes for In Vitro Diagnostic (IVD) Tests.” FDA notes that with the use of electronic health records (EHR), there has been a greater demand to standardize the way that IVDs are coded. The document discusses how laboratories commonly associate a LOINC (Logical Observation Identifiers Names and Codes) with each test being performed. “It is important to distinguish between LOINC codes and Unique Device Identifiers (UDIs),” it says. The LOINC coding system identifies the type of laboratory test being performed, and the UDI identifies a specific model/version of a regulated laboratory device made by a specific manufacturer.” To view the guidance, click [here](https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM610636.pdf?ref=fdaweb.com).