Recognized standard
GP23-A2 (Replaces GP23-A)
FDA recognition 7-259 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-259 |
|---|---|
| Designation | GP23-A2 (Replaces GP23-A) |
| Title | Nongynecological Cytology Specimens: Preexamination, Examination, and Postexamination Processes; Approved Guideline - Second Edition |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Apr 4, 2016 |
| Device classes | Class 1 |
| Scope (excerpt) | This document provides recommendations for cytology laboratories to use in developing preexamination, examination, and postexamination processes and procedures for nongynecological cytology specimen management. |
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: