In vitro diagnostic medical device (IVD)
The standard’s wording, as the sources below reproduce it:
“Indicates a medical device that is intended to be used as an in vitro diagnostic medical device.”
ISO 15223-1:2021, 5.5.1
What it means for you
“In vitro” means outside the body: the product tests a sample — blood, urine, saliva, a swab — rather than being used on or in you. Pregnancy tests, COVID-19 and flu antigen tests, glucose strips and lab reagents are IVDs.
Whether a device is right for you is a question for your pharmacist, nurse or doctor.
- What it looks like
- The letters IVD inside a rectangle.
- Where you see it
- Home tests, blood-glucose and ketone strips, control solutions and laboratory reagents.
- Other names
- IVD; for in vitro diagnostic use
What it does not tell you
It does not say who may use the test (self-testing, near-patient or laboratory only), how accurate it is, or what a result means for you.
Often confused with
Indicates the item is a medical device.
More symbols in “Letters”
Sources
ISO 15223-1 is a paid standard, so the wording above is quoted as 3 publishers’ public documents reproduce it. Each was fetched and read on the date shown:
- Stago: Glossary of symbols (520233-A_EN) — “In vitro diagnostic medical device — Indicates a medical device that is intended to be used as an in vitro diagnostic medical device. NF EN ISO 15223-1, symbol #5.5.1.” Checked 2026-09-25.
- NE Scientific: Master Symbol Glossary (CTF-100011 Rev 01) — Shows IVD in a box for reference no. 5.5.1, with the same wording. Checked 2026-09-25.
- BÜHLMANN Laboratories: Symbol glossary, version 03 (release date 2025-02-04) — “In vitro diagnostic medical device — Indicates a medical device that is intended to be used as an in vitro diagnostic medical device.” Checked 2026-09-25.
Plain-language parts are in our own words; quotations are the sources’ wording.