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CLSI Standards: Guidelines for Health Care Excellence

Developed by our members for use by the global laboratory community, CLSI’s consensus-based medical laboratory standards are the most widely recognized resources for continually improving testing quality, safety, and efficiency.

Browse our collection of consensus-based medical laboratory standards documents. Choose from print or electronic versions of CLSI standards and guidelines.

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Effective 04 January 2024, CLSI is pleased to offer Country-Based Pricing for customers who meet established economic criteria. Visit our Country-Based Pricing page for more information about this new program. Note: Discounted pricing is available only when a customer is logged in to his/her CLSI account.

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Human Genetic and Genomic Testing Using Traditional and High-Throughput Nucleic Acid Sequencing Methods, 3rd Edition

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One-Stage Prothrombin Time (PT) Test and Activated Partial Thromboplastin Time (APTT) Test, 3rd Edition

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Evaluation of Qualitative, Binary Output Examination Performance, 3rd Edition

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Performance Standards for Susceptibility Testing of Mycobacteria, Nocardia spp., and Other Aerobic Actinomycetes, 2nd Edition

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Medical laboratories — Requirements for quality and competence
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A Framework for Using CLSI Documents to Evaluate Medical Laboratory Test Methods, 3rd Edition

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In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing
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In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing
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In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use
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In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use
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