Recognized standard
POCT14 2nd Edition
FDA recognition 7-299 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-299 |
|---|---|
| Designation | POCT14 2nd Edition |
| Title | Point-of-Care Coagulation Testing and Anticoagulation Monitoring |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Dec 21, 2020 |
| Device classes | Class 2 |
| Scope (excerpt) | This guideline provides recommendations for establishing and/or assessing performance characteristics of traditional assays for coagulation assessment and anticoagulation management that are performed at the point of care (POC). These tests include those used for monitoring vitamin K antagonists… |
At a glance
- 10–99 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: