Recognized standard
AUTO12-A
FDA recognition 13-31 · CLSI · Software/Informatics
Key facts
| Recognition number | 13-31 |
|---|---|
| Designation | AUTO12-A |
| Title | Specimen Labels: Content and Location, Fonts, and Label Orientation; Approved Standard |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | Software/Informatics |
| Date of entry | Aug 20, 2012 |
| Scope (excerpt) | Clinical and Laboratory Standards Institute document AUTO12-A--Specimen Labels: Content and Location, Fonts, and Label Orientation; Approved Standard was developed to reduce the unacceptably high incidence of mislabeled specimens in clinical laboratories. The standard specifies locations and formats… |
At a glance
- None Product codes
- 1–9 FDA guidance documents
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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: