Recognized standard
EP37 1st Edition
FDA recognition 7-284 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-284 |
|---|---|
| Designation | EP37 1st Edition |
| Title | Supplemental Tables for Interference Testing in Clinical Chemistry |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Sep 17, 2018 |
| Device classes | Class 2 |
| Scope (excerpt) | The supplemental tables presented in EP37 are intended for use with the evaluation procedures presented in CLSI document EP07. The supplemental table in EP37 provide recommended test concentrations for analytes and endogenous substances that may interfere in measurement procedures. |
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: