Recognized standard
C31-A2 (Replaces C31-A)
FDA recognition 7-87 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-87 |
|---|---|
| Designation | C31-A2 (Replaces C31-A) |
| Title | Ionized Calcium Determinations: Precollection Variables, Specimen Choice, Collection, and Handling; Approved Guideline - Second Edition. |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Mar 8, 2004 |
| Device classes | Class 2 |
| Scope (excerpt) | This document addresses preanalytical considerations--such as patient condition, specimen choice, collection, and handling--that can influence accuracy and clinical utility of ionized calcium measurements. |
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: