Recognized standard
H15-A3 (Replaces H15-A2)
FDA recognition 7-71 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-71 |
|---|---|
| Designation | H15-A3 (Replaces H15-A2) |
| Title | Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood; Approved Standard - Third Edition |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Mar 18, 2009 |
| Device classes | Class 2 |
| Scope (excerpt) | This document describes the principle, materials, and procedure for reference and standardized hemoglobin determinations. It includes specifications for secondary hemiglobincyanide (HiCN) standards. |
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: