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.

LOINCActiveBoth

LOINC Code 85482-8: FDA product label Human cell and tissue establishment registration and product listing

Name: LOINC Code 85482-8: FDA product label Human cell and tissue establishment registration and product listing
Creator: HealthAssure Clinical Team
Published: 2026-05-21T09:00:13.315Z

85482-8 is a LOINC code used to identify FDA product label Human cell and tissue establishment registration and product listing 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 Human cell and tissue establishment registration & product listing. It is commonly used with the system or sample type ^FDA product label.

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 Human cell and tissue establishment registration & product listing. It is commonly used with the system or sample type ^FDA product label.

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: Both

What it does not mean

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

Key facts

FDA product label Human cell and tissue establishment registration and product listing
Human cell and tissue establishment registration & product listing
Cell Tiss Est Reg; DOCUMENT.REGULATORY; FDA label; Narrative; Report

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 product label Human cell and tissue establishment registration and product listingFDA label Cell Tiss Est RegHuman cell and tissue establishment registration & product listingDOCUMENT.REGULATORY-^FDA product labelNar

Frequently asked questions

Code details

Code85482-8

SystemLOINC

Display nameFDA product label Human cell and tissue establishment registration and product listing

DescriptionHuman cell and tissue establishment registration & product listing

Short nameFDA label Cell Tiss Est Reg

ComponentHuman cell and tissue establishment registration & product listing

Property-

Timing-

System (specimen)^FDA product label

ScaleNar

ClassDOCUMENT.REGULATORY

StatusACTIVE

Order/ObservationBoth

Flags

BillableNo

Valid clinical useNo

Source

SourceLOINC

Version2.82

Releasemain

First released2.61

Last changed2.61

Part names

Human cell and tissue establishment registration & product listing-^FDA product labelNarHuman cell and tissue establishment registration and product listing

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.