• CLSI EP25-P

CLSI EP25-P

Evaluation of Stability of In Vitro Diagnostic Method Products; Proposed Guideline, EP25PE

Clinical and Laboratory Standards Institute, 12/01/2008

Publisher: CLSI

File Format: PDF

$123.00$247.77


Published:01/12/2008

Pages:40

Clinical and Laboratory Standards Institute document EP25-P--Evaluation of Stability of In Vitro Diagnostic Method Products; Proposed Guideline provides guidance and regression-based procedures for establishing stability-related claims of IVD method products such as reagent kits, calibrators, control products, and sample diluents. This guideline was written primarily for manufacturers and regulatory agencies, but also will be of interest to clinical laboratories. It provides information on the design, implementation, data analysis, and documentation needs for studies to establish and verify shelf life and in-use life of method products. Additional topics address assessment of product transport conditions on stability and accelerated stability testing.

More CLSI standard pdf

CLSI QMS12

CLSI QMS12

Developing and Using Quality Indicators for Laboratory Improvement, 2nd Edition, QMS12Ed2E

$90.00 $180.00

CLSI M07-Ed11 and M100-Ed29 Package

CLSI M07-Ed11 and M100-Ed29 Package

Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically, Eleventh Edition, M07Ed11E; Performance Standards for Antimicrobial Susceptibility Testing, Twenty-Ninth Edition, M100Ed29E

$171.00 $342.00

CLSI M02-Ed13, M07-Ed11, and M100-Ed29 Package

CLSI M02-Ed13, M07-Ed11, and M100-Ed29 Package

Performance Standards for Antimicrobial Disk Susceptibility Tests, 13th Edition, M02Ed13E; Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically, 11th Edition, M07Ed11E; Performance Standards for Antimicrobial Susceptibility Testing, 29th Edition, M100Ed29E

$252.00 $504.00

CLSI C34

CLSI C34

Sweat Testing: Specimen Collection and Quantitative Chloride Analysis, 4th Edition, C34Ed4E

$90.00 $180.00