What does this LOINC code represent?

This LOINC code identifies a lab observation, measurement, question, or clinical concept in a standardized format.

Is this enough to understand my test result?

No. The code identifies the test or observation, but the interpretation depends on the actual result, reference range, and clinical context.

LOINCActiveObservation

LOINC Code 82345-0: FDA package insert REMS elements to assure safe use

Name: LOINC Code 82345-0: FDA package insert REMS elements to assure safe use
Creator: HealthAssure Clinical Team
Published: 2026-05-21T09:00:08.165Z

82345-0 is a LOINC code used to identify FDA package insert REMS elements to assure safe use in laboratory and clinical observation data. You may see this code in lab systems, lab reports, EHR exports, interoperability feeds, or other structured clinical data exchanges. LOINC codes identify tests, measurements, observations, survey items, and clinical questions in a standardized way. It is associated with the component REMS elements to assure safe use. It is commonly used with the system or sample type ^FDA package insert.

Reviewed by HealthAssure Clinical TeamUpdated 21 May 2026

What is this code?

LOINC codes identify tests, measurements, observations, survey items, and clinical questions in a standardized way. It is associated with the component REMS elements to assure safe use. It is commonly used with the system or sample type ^FDA package insert.

When is it used?

Used in lab systems, EHRs, and clinical data exchange.
May identify a test, observation, survey item, or clinical document request rather than a diagnosis.
Status: ACTIVE
Order vs observation: Observation

What it does not mean

The code identifies the observation or test, not the actual result.

Key facts

FDA package insert REMS elements to assure safe use
REMS elements to assure safe use
DOCUMENT.REF; FDA insert; Narrative; REMS elmnts assure safe use; Report; SPL; Structured Product Labelling

Where you may see this code

You may see this code in lab systems, lab reports, EHR exports, interoperability feeds, or other structured clinical data exchanges.

Common synonyms

FDA package insert REMS elements to assure safe useFDA insert REMS elmnts assure safe useREMS elements to assure safe useDOC.REF-^FDA package insertNar

Frequently asked questions

Code details

Code82345-0

SystemLOINC

Display nameFDA package insert REMS elements to assure safe use

DescriptionREMS elements to assure safe use

Short nameFDA insert REMS elmnts assure safe use

ComponentREMS elements to assure safe use

Property-

Timing-

System (specimen)^FDA package insert

ScaleNar

ClassDOC.REF

StatusACTIVE

Order/ObservationObservation

Flags

BillableNo

Valid clinical useNo

Source

SourceLOINC

Version2.82

Releasemain

First released2.58

Last changed2.58

Part names

REMS elements to assure safe use-^FDA package insertNar

About this content

This page is prepared by HealthAssure's clinical team using official coding standards from LOINC. AI tools assist with drafting explanations, which are then reviewed and verified by healthcare professionals for accuracy. This content is for informational purposes and does not replace professional medical advice. Meet our team.