Recognized standard
EP34 1st Edition
FDA recognition 7-290 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-290 |
|---|---|
| Designation | EP34 1st Edition |
| Title | Establishing and Verifying an Extended Measuring Interval Through Specimen Dilution and Spiking |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Jul 15, 2019 |
| Scope (excerpt) | EP34 provides recommendations for establishing a dilution scheme to be used for patient specimens that contain measurand concentrations in the extended measuring interval above a measurement procedure's upper limit of quantitation. Guidance is provided on determining, validating, and verifying the… |
At a glance
- None Product codes
- 1–9 FDA guidance documents
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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: