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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 031 Date of Recognition 08/06/2013 
FR Recognition Number 13-37
Standard
CLSI AUTO7-A
Laboratory Automation: Data Content for Specimen Identification; Approved Standard
Scope/Abstract
This document provides specifications for the content of linear bar codes on specimen container tubes in the clinical laboratory and for use on laboratory automation systems.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§862.2100 Calculator/Data Processing Module, For Clinical Use Class 1 JQP
Relevant FDA Guidance and/or Supportive Publications
There is no relevant guidance developed at this time.
FDA Technical Contact
 James Mullally
  FDA/OMPT/CDRH/OIR/DCTD/CTXB/
  240-402-5021
  james.mullally@fda.hhs.gov
Standards Development Organization
CLSI Clinical Laboratory Standards Institute https://clsi.org/
FDA Specialty Task Group (STG)
Software/Informatics
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