Recognized standard
GP42 7th Edition
FDA recognition 7-301 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-301 |
|---|---|
| Designation | GP42 7th Edition |
| Title | Collection of Capillary Blood Specimens |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Dec 21, 2020 |
| Device classes | Class 2 |
| Scope (excerpt) | This standard describes the process and related procedures for collecting diagnostic capillary blood specimens, including capillary blood gases. It is intended for health care professionals responsible for obtaining specimens from patients, as well as for manufacturers of capillary puncture and… |
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: