Recognized standard
H59-A (Replaces H59-P)
FDA recognition 7-220 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-220 |
|---|---|
| Designation | H59-A (Replaces H59-P) |
| Title | Quantitative D-dimer for the Exclusion of Venous Thromboembolic Disease; Approved Guideline. |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Jan 30, 2014 |
| Device classes | Class 2 |
| Scope (excerpt) | This document provides guidelines regarding the use of D-dimer in exclusion of venous thromboembolism (VTE) including a description of the value of clinical determination of the pretest probability of VTE; the proper collection and handling of the specimen; assays used for D-dimer analysis… |
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: