Recognized standard
EP32-R (Formerly X05-R)
FDA recognition 7-239 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-239 |
|---|---|
| Designation | EP32-R (Formerly X05-R) |
| Title | Metrological Traceability and Its Implementation; A Report |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Jan 30, 2014 |
| Scope (excerpt) | This document provides guidance to manufacturers for establishing and reporting metrological traceability. |
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: