Standard Document
Sixth Edition
Preexamination Processes

CLSI GP39

Tubes and Additives for Venous and Capillary Blood Specimen Collection

This standard outlines the requirements for the materials, manufacturing, and labeling of venous and capillary blood collection devices. it ensures that these devices meet the necessary quality and safety standards. 

December 29, 2010
Nancy Dubrowny, MS, MT(ASCP)SC

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Abstract

Clinical and Laboratory Standards Institute document GP39-A6—Tubes and Additives for Venous and Capillary Blood Specimen Collection; Approved Standard—Sixth Edition is a performance standard for manufacturers of venous and capillary blood collection tubes and additives for serum, plasma, and whole blood testing. GP39 addresses requirements for the materials, construction, and labeling of venous and capillary blood collection tubes and tube assemblies.

Scope

This document addresses requirements for the materials, manufacturing, and labeling of venous and capillary blood collection devices. Capillary blood collection devices addressed in this document include only microcollection devices (see Section 3.2). 

The document also provides a description, mode of action, and specifications for most common anticoagulants found in blood collection devices.

Product Details
GP39A6E
1-56238-740-5
32
Additional Details

The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.

This document is available in electronic format only.

This archived document is no longer being reviewed through the CLSI Consensus Document Development Process. However, this document is technically valid and because of its value to the laboratory community, it is being retained in CLSI’s library.

Authors
Nancy Dubrowny, MS, MT(ASCP)SC
Elizabeth Armstrong, MT(ASCP)
Julie Berube, PhD
Raffick A. R. Bowen, MLT(CSMLS), PhD, DClChem, FCACB, DABCC
Yung W. Chan, MT(ASCP)
Daniel Hesselgesser, MT(ASCP)
Susan S. Smith
Ana K. Stankovic, MD, PhD, MSPH
Diane I. Szamosi, MA, MT(ASCP)SH
Abstract

Clinical and Laboratory Standards Institute document GP39-A6—Tubes and Additives for Venous and Capillary Blood Specimen Collection; Approved Standard—Sixth Edition is a performance standard for manufacturers of venous and capillary blood collection tubes and additives for serum, plasma, and whole blood testing. GP39 addresses requirements for the materials, construction, and labeling of venous and capillary blood collection tubes and tube assemblies.

Scope

This document addresses requirements for the materials, manufacturing, and labeling of venous and capillary blood collection devices. Capillary blood collection devices addressed in this document include only microcollection devices (see Section 3.2). 

The document also provides a description, mode of action, and specifications for most common anticoagulants found in blood collection devices.

Additional Details

The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.

This document is available in electronic format only.

This archived document is no longer being reviewed through the CLSI Consensus Document Development Process. However, this document is technically valid and because of its value to the laboratory community, it is being retained in CLSI’s library.

Authors
Nancy Dubrowny, MS, MT(ASCP)SC
Elizabeth Armstrong, MT(ASCP)
Julie Berube, PhD
Raffick A. R. Bowen, MLT(CSMLS), PhD, DClChem, FCACB, DABCC
Yung W. Chan, MT(ASCP)
Daniel Hesselgesser, MT(ASCP)
Susan S. Smith
Ana K. Stankovic, MD, PhD, MSPH
Diane I. Szamosi, MA, MT(ASCP)SH