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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 036 Date of Entry 07/09/2014 
FR Recognition Number 7-142
CLSI GP43-A4 (Formerly H11-A4) Procedures for the Collection of Arterial Blood Specimens; Approved Standard -- Fourth Edition
Scope/Abstract
This document provides principles for collecting, handling, and transporting arterial blood specimens to assist with reducing collection hazards and ensuring the integrity of the arterial specimen.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§862.1675 Tray, Blood Collection Class 2 GJE
§862.1675 Tubes, Vacuum Sample, With Anticoagulant Class 2 GIM
§862.1675 Tubes, Vials, Systems, Serum Separators, Blood Collection Class 2 JKA
FDA Technical Contact
 Yung Chan
  FDA/OMPT/CDRH/OIR/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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