Recognized standard
GP44-A4 (Formerly H18-A4)
FDA recognition 7-213 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-213 |
|---|---|
| Designation | GP44-A4 (Formerly H18-A4) |
| Title | Procedures for the Handling and Processing of Blood Specimens for Common Laboratory Tests; Approved Guideline-Fourth Edition |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Jul 9, 2014 |
| Device classes | Class 2, Class 1 |
| Scope (excerpt) | This standard considers multiple variables that are involved in handling and processing blood specimens. Its application should enable the user to recognize and control accuracy and precision factors that occur between the time of blood collection and the time of test 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: