Recognized standard
H7-A3
FDA recognition 7-104 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-104 |
|---|---|
| Designation | H7-A3 |
| Title | Procedure for Determining Packed Cell Volume by the Microhematocrit Method - Second Edition; Approved Standard - Third Edition. |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Oct 4, 2004 |
| Device classes | Class 2 |
| Scope (excerpt) | The standard is intended for reference use by clinical laboratory personnel and by manufacturers of instruments that determine PCV. The method can also be used (with appropriate precautions as described in the document) in the clinical laboratory for diagnostic purposes, for monitoring a patient's… |
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: