Recognized standard
C62-A
FDA recognition 7-265 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-265 |
|---|---|
| Designation | C62-A |
| Title | Liquid Chromatography-Mass Spectrometry Methods; Approved Guideline. |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Sep 21, 2016 |
| Scope (excerpt) | This document provides guidance to the clinical laboratorian for the reduction of interlaboratory variance and the evaluation of interferences, assay performance, and other pertinent characteristics of clinical assays. This guideline emphas particular areas related to assay development and presents… |
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: