Recognized standard
EP07 3rd Edition
FDA recognition 7-275 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-275 |
|---|---|
| Designation | EP07 3rd Edition |
| Title | Interference Testing in Clinical Chemistry. |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Sep 17, 2018 |
| Scope (excerpt) | This guideline is intended for manufacturers and medical laboratories. EP07 assists manufacturers and other developers of laboratory measurement procedures in characterizing the effects of potential interferents on measurement procedures results. EP07 also contains background information on… |
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: