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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 028 Date of Entry 03/16/2012 
FR Recognition Number 7-225
Standard
CLSI GP34-A (Replaces GP34-P)
Validation and Verfication of Tubes for Venous and Capillary Blood Specimen Collection; Approved Guidance
Scope/Abstract
This document is a guideline for manufacturers of venous and capillary blood collection tubes and users of blood collection tubes for serum, plasma, and whole blood testing. GP34 provides guidelines for validation and verification of test (examination) performance.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§862.1675 Tubes, Vials, Systems, Serum Separators, Blood Collection Class 2 JKA
Relevant FDA Guidance and/or Supportive Publications*
GP39-A6 Tubes and Additives for Venous and Capillary Blood Specimen Collection; Approved Standard -Sixth Edition.
FDA Technical Contact
 Yung Chan
  FDA/OC/CDRH/OPEQ/OIDRH/DCTD/
  301-796-6138
  yung.chan@fda.hhs.gov
Standards Development Organization
CLSI Clinical Laboratory Standards Institute https://clsi.org/
FDA Specialty Task Group (STG)
InVitro Diagnostics
*These are provided as examples and others may be applicable.
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