Recognized standard
POCT04 3rd Edition
FDA recognition 7-283 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-283 |
|---|---|
| Designation | POCT04 3rd Edition |
| Title | Essential Tools for Implementation and Management of a Point-of-Care Testing Program |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Sep 17, 2018 |
| Scope (excerpt) | Many potential sites are eligible for point-of-care testing (POCT). To achieve producing patient test results comparable with those from the medical laboratory, this guideline provides essential tools for implementing and managing POCT in both clinical and nonclinical settings. |
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: