Recognized standard
GP34-A (Replaces GP34-P)
FDA recognition 7-225 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-225 |
|---|---|
| Designation | GP34-A (Replaces GP34-P) |
| Title | Validation and Verfication of Tubes for Venous and Capillary Blood Specimen Collection; Approved Guidance |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Mar 16, 2012 |
| Device classes | Class 2 |
| Scope (excerpt) | This document is a guideline for manufacturers of venous and capillary blood collection tubes and users of blood collection tubes for serum, plasma, and whole blood testing. GP34 provides guidelines for validation and verification of test (examination) performance. |
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: