Recognized standard
AUTO2-A2
FDA recognition 13-9 · CLSI · Software/Informatics
Key facts
| Recognition number | 13-9 |
|---|---|
| Designation | AUTO2-A2 |
| Title | Laboratory Automation: Bar Codes for Specimen Container Identification |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | Software/Informatics |
| Date of entry | Sep 9, 2008 |
| Device classes | Class 1 |
| Scope (excerpt) | Clinical and Laboratory Standards Institute document AUTO2-A2 - Laboratory Automation: Bar Codes for Specimen Container Identification; Approved Standard - Second Edition defines the way bar-coded sample identification labels are applied to clinical specimen containers. It documents the form… |
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: