Recognized standard
EP37 2nd Edition
FDA recognition 7-348 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-348 |
|---|---|
| Designation | EP37 2nd Edition |
| Title | Supplemental Tables for Interference Testing in Clinical Chemistry |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Dec 22, 2025 |
| Device classes | Class 2 |
| Scope (excerpt) | This product is a database tool that updates the first edition of the original CLSI EP37 document and converts the guidance into an interactive application. It continues to provide recommended testing concentrations for analytes and endogenous substances that may affect clinical chemistry… |
At a glance
- 1–9 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: