Recognized standard
GP16-A3 (Replaces GP16-A2)
FDA recognition 7-207 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-207 |
|---|---|
| Designation | GP16-A3 (Replaces GP16-A2) |
| Title | Urinalysis; Approved Guideline - Third Edition |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | May 5, 2010 |
| Scope (excerpt) | This document addresses procedures for testing urine, including materials and equipment; macroscopic/physical evaluation; chemical analysis; and microscopic analysis. |
At a glance
- None 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: