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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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05/29/2024 InVitro Diagnostics 7-321 Partial CLSI MM24 1st Edition Molecular Methods for Genotyping and Strain Typing of Infectious Organisms
12/18/2023 InVitro Diagnostics 7-320 Partial CLSI H62 1st Edition Validation of Assays Performed by Flow Cytometry
12/18/2023 InVitro Diagnostics 7-319 Complete CLSI M23 6th Edition Development of In Vitro Susceptibility Test Methods, Breakpoints, and Quality Control Parameters
12/18/2023 InVitro Diagnostics 7-318 Complete CLSI EP25 2nd Edition Evaluation of Stability of In Vitro Medical Laboratory Test Reagents
05/29/2023 InVitro Diagnostics 7-317 Partial CLSI M100, 33rd Edition Performance Standards for Antimicrobial Susceptibility Testing
05/29/2023 InVitro Diagnostics 7-316 Complete CLSI NBS01 7th Edition Dried Blood Spot Specimen Collection for Newborn Screening
05/29/2023 InVitro Diagnostics 7-315 Complete CLSI EP12 3rd Edition Evaluation of Qualitative, Binary Output Examination Performance
12/19/2022 InVitro Diagnostics 7-314 Partial CLSI M27M44S, 3rd Edition Performance Standards for Antifungal Susceptibility Testing of Yeasts
12/19/2022 InVitro Diagnostics 7-313 Complete CLSI EP27 2nd Edition Constructing and Interpreting an Error Grid for Quantitative Measurement Procedures
12/20/2021 InVitro Diagnostics 7-311 Complete CLSI EP39, 1st Edition A Hierarchical Approach to Selecting Surrogate Samples for the Evaluation of In Vitro Medical Laboratory Tests
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