Recognized standard
C39-A (Replaces C39-P)
FDA recognition 7-89 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-89 |
|---|---|
| Designation | C39-A (Replaces C39-P) |
| Title | A Designated Comparison Method for the Measurement of Ionized Calcium in Serum; Approved Standard |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Mar 8, 2004 |
| Device classes | Class 2 |
| Scope (excerpt) | This document describes a designated comparison method to standardize the ionized calcium measurements made by ion-selective electrode (ISE) potentiometry. |
At a glance
- 1–9 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: