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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 020 FR Publication Date: 09/09/2008 

Part B: Supplementary Information

Recognition Number 13-9: CLSI / NCCLS AUTO2-A2, laboratory automation: bar codes for specimen container identification. (Software/Informatics)

Date of Standard: 2006. 
Addresses of Standards Development Organizations:
 Clinical Laboratory Standards Institute (CLSI)
  950 West Valley Road
  Suite 2500
  Wayne, PA 19087
 
 National Committee for Clinical Laboratory Standards (NCCLS)
  950 West Valley Road
  Suite 2500
  Wayne, PA 19087
 
CDRH Offices and Divisions associated with recognized standards:
(1)OFFICE OF DEVICE EVALUATION (ODE)
(2)OFFICE OF COMPLIANCE (OC)
Devices Affected:
Auto Analyses, Reagent Containers
Processes Affected:
510(k), PMA, PDP
Type of Standard:
 International, Horizontal
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§862.2100 Calculator/Data Processing Module, For Clinical Use Class 1 JQP
§864.3250 Container, Specimen Mailer And Storage, Sterile Class 1 KDT
§864.3250 Container, Specimen Mailer And Storage, Temperature Controlled, Sterile Class 1 KDW
§864.3250 Container, Specimen, Sterile Class 1 FMH
FDA Technical Contact:
 James Callaghan
  FDA/CDRH/OIR
  10903 New Hampshire Avenue Building 66, Room 5658
  Silver Spring MD 20993
  301/796-6137
  email: james.callaghan@fda.hhs.gov
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