Recognized standard
GP39-A6 (Formerly H01-A6)
FDA recognition 7-221 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-221 |
|---|---|
| Designation | GP39-A6 (Formerly H01-A6) |
| Title | Tubes and Additives for Venous Blood Specimen Collection; Approved Standard-Sixth Edition |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Jul 9, 2014 |
| Device classes | Class 2 |
| Scope (excerpt) | This document is a performance standard for manufacturers of venous and capillary blood collection tubes and additives for serum, plasma, and whole blood testing. H01 addresses requirements for the materials, construction, and labeling of venous and capillary blood collection tubes and tube… |
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: