TS EN 375

TS EN 375 is a standard for the labelling of in vitro diagnostic reagents intended for professional use. Its subject is the way laboratory diagnostic reagents are identified and presented so that users can recognize the product correctly, understand its intended use, and obtain the essential information needed for routine handling and interpretation. Although withdrawn, it remains a useful technical reference for understanding the logic of IVD labelling.

Why labelling matters in IVD practice

For in vitro diagnostic reagents, the label is more than a commercial identifier: it is the primary source of product identity, intended use, and key handling information for laboratory staff. Reagents can look similar while differing in analyte target, working range, format, stability, or storage conditions. Clear labelling helps reduce mix-ups and supports consistent use in a professional laboratory setting.

Professional use in the laboratory context

“Professional use” means the product is meant to be used by trained personnel within a laboratory workflow. In vitro diagnostic reagents are used to test samples outside the body in areas such as clinical chemistry, immunology, microbiology, and related diagnostic disciplines. In that setting, the label needs to communicate the reagent’s identity and its basic conditions for use in a way that is immediately understandable to laboratory users.

From a general technical standpoint, standards of this kind link nomenclature to practical reliability. Different lots, kit components, or storage requirements can exist within the same product family, so robust labelling helps minimize product confusion and the risk of incorrect test use or misinterpretation. The focus of TS EN 375 is the presentation of that information, not a full analytical test method for reagent performance.