Recognized standard
C42-A
FDA recognition 7-21 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-21 |
|---|---|
| Designation | C42-A |
| Title | Erythrocyte Protoporphyrin Testing; Approved Guideline |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Sep 9, 2008 |
| Device classes | Class 1 |
| Scope (excerpt) | This document contains recommendations for the measurement, reporting, and interpretation of erythrocyte protoporphyrin using hematofluorometric and extraction measurement methods. |
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: