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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Keyword: Measurement Procedure Comparison
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09/21/2016 InVitro Diagnostics 7-265 Partial CLSI C62-A Liquid Chromatography-Mass Spectrometry Methods; Approved Guideline.
08/21/2017 InVitro Diagnostics 7-270 Complete CLSI I/LA-20 3rd Edition (Replaces I/LA20-A3) Analytical Performance Characteristics, Quality Assurance, and Clinical Utility of Immunological Assays for Human Immunoglobulin E Antibodies of Defined Allergen Specificities
08/21/2017 InVitro Diagnostics 7-272 Partial CLSI C57 1st Edition (Reaffirmed: January 2020) Mass Spectrometry for Androgen and Estrogen Measurements in Serum
08/21/2017 InVitro Diagnostics 7-273 Complete CLSI M58 1st Edition Methods for Identification of Cultured Microorganisms Using Matrix-Assisted Laser Desorption/Ionization Time-of-Flight Mass Spectrometry
07/06/2020 InVitro Diagnostics 7-296 Partial CLSI EP09c 3rd Edition Measurement Procedure Comparison and Bias Estimation Using Patient Samples
12/23/2016 InVitro Diagnostics 7-268 Partial CLSI EP21 2nd Edition (Replaces EP21-A) Evaluation of Total Analytical Error for Quantitative Medical Laboratory Measurement Procedures
 
 
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