Recognized standard
GP20-A2 (Replaces GP20-A)
FDA recognition 7-166 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-166 |
|---|---|
| Designation | GP20-A2 (Replaces GP20-A) |
| Title | Fine Needle Aspiration Biopsy (FNAB) Techniques; Approved Guideline - Second Edition |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Mar 16, 2012 |
| Device classes | Class 1 |
| Scope (excerpt) | This document contains recommended procedures for performing fine needle aspiration biopsies of superficial (palpable) and deep-seated (nonpalpable) lesions/masses, from patient preparation through staining the smear. |
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: