Recognized standard
LIS07-A
FDA recognition 13-22 · CLSI · Software/Informatics
Key facts
| Recognition number | 13-22 |
|---|---|
| Designation | LIS07-A |
| Title | Standard Specification for Use of Bar Codes on Specimen Tubes in the Clinical Laboratory |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | Software/Informatics |
| Date of entry | Sep 9, 2008 |
| Device classes | Class 1 |
| Scope (excerpt) | This specification identifies the way bar coded sample identification labels are applied to clinical specimen containers. It documents the form, placement, and content of bar code labels on specimen tubes that are used on clinical laboratory analyzers. It enables Laboratory Information System… |
At a glance
- 1–9 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: