Recognized standard
AUTO01-A
FDA recognition 7-332 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-332 |
|---|---|
| Designation | AUTO01-A |
| Title | Laboratory Automation: Specimen Container/Specimen Carrier; Approved Standard |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | May 26, 2025 |
| Device classes | Class 1 |
| Scope (excerpt) | This document provides standards for the design and manufacture of specimen containers and carriers used for collecting and processing liquid samples, such as blood and urine, for clinical testing in laboratory automation systems. |
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: