Celebrate Lab Week 2019 with CLSI.
Celebrate Lab Week 2019 with CLSI.


Quality System Regulations for Laboratory Developed Tests: A Practical Guide for the Laboratory

This practical guide, compiled with the help of experts from the in vitro diagnostics industry, is intended for the laboratory that is creating laboratory developed tests that may be subject to the US Food and Drug Administration (FDA) regulations, specifically the Quality System Regulation (QSReg), 21 CFR Part 820. 

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Publication Details

Date of Publication: January 22, 2015


Order Code Print: QSRLDT

Edition: First

Pages: 150