Recognized standard
C57 1st Edition (Reaffirmed: January 2020)
FDA recognition 7-272 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-272 |
|---|---|
| Designation | C57 1st Edition (Reaffirmed: January 2020) |
| Title | Mass Spectrometry for Androgen and Estrogen Measurements in Serum |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Aug 21, 2017 |
| Scope (excerpt) | This document is intended to aid the laboratorian in developing appropriate procedures for the use of mass spectrometry (MS) in the measurement of androgens and estrogens. The primary objectives of this document are to provide guidance and establish uniform practices necessary for producing quality… |
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: