Recognized standard
EP25 2nd Edition
FDA recognition 7-318 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-318 |
|---|---|
| Designation | EP25 2nd Edition |
| Title | Evaluation of Stability of In Vitro Medical Laboratory Test Reagents |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Dec 18, 2023 |
| Scope (excerpt) | This guideline provides information for establishing and verifying (confirming) shelf-life and in-use stability claims for quantitative in vitro diagnostic (IVD) medical laboratory reagents or products. The information also applies to qualitative IVD products, provided that an underlying continuous… |
At a glance
- None Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: