Recognized standard
H30-A2
FDA recognition 7-105 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-105 |
|---|---|
| Designation | H30-A2 |
| Title | Procedure for the Determination of Fibrinogen in Plasma; Approved Guideline Second Edition |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Oct 4, 2004 |
| Device classes | Class 2 |
| Scope (excerpt) | This document provides general guidelines for performing the fibrinogen assay in the clinical laboratory. It also includes reporting of results and in vivo and in vitro conditions that may alter results. |
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: