Recognized standard
EP25-A (Replaces EP25-P)
FDA recognition 7-235 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-235 |
|---|---|
| Designation | EP25-A (Replaces EP25-P) |
| Title | Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline. |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Jan 15, 2013 |
| Scope (excerpt) | This document provides guidance and regression-based procedures for establishing stability-related claims of in vitro diagnostic (IVD) reagents such as reagent kits, calibrators, control products, and sample diluents. This guideline was written primarily for manufacturers and regulatory agencies… |
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: