Recognized standard
GP41 7th Edition
FDA recognition 7-277 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-277 |
|---|---|
| Designation | GP41 7th Edition |
| Title | Collection of Diagnostic Venous Blood Specimens |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Sep 17, 2018 |
| Device classes | Class 2 |
| Scope (excerpt) | This standard establishes criteria for suitable venous blood specimen collection for medical laboratory testing. These procedures are intended as an appropriate model for adoption by all health care providers responsible for blood specimen collection in outpatient and inpatient settings. |
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: