| CLSI LIS07-A Standard Specification for Use of Bar Codes on Specimen Tubes in the Clinical Laboratory |
| Recognition Date | 2008-09-09 |
| Recognition List | 020 |
| Recognition Number | 13-22 |
| Extent | Complete standard |
| Standards Orgs | CLSI Clinical Laboratory Standards Institute https://clsi.org/ |
| STG | Software/Informatics |
| FDA Tech | James Mullally FDA/OMPT/CDRH/OIR/DCTD/CTXB/ 240-402-5021 james.mullally@fda.hhs.gov |
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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 vendors to produce reliable bar coded symbols that are readable by any complying clinical laboratory analyzer vendor.
| Regulation Number | Device Name | Device Class | Product Code |
| §862.2100 | Calculator/Data Processing Module, For Clinical Use | Class 1 | JQP |
| There is no relevant guidance developed at this time. |