Recognized Consensus Standards: Medical Devices
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1 to 10 of 114 Results
Specialty Task Group Area: InVitro Diagnostics |
Results per Page |
Date of
Entry |
Specialty Task
Group Area |
Recognition
Number |
Extent of
Recognition |
Standards
Developing Organization |
Standard Designation Number and Date |
Standard Title (click for recognition information) |
07/06/2020 | InVitro Diagnostics | 7-298 | Complete | CLSI | EP35, 1st Edition | Assessment of Equivalence or Suitability of Specimen Types for Medical Laboratory Measurement Procedures |
10/04/2004 | InVitro Diagnostics | 7-104 | Complete | CLSI | H7-A3 | Procedure for Determining Packed Cell Volume by the Microhematocrit Method - Second Edition; Approved Standard - Third Edition. |
03/18/2009 | InVitro Diagnostics | 7-180 | Complete | CLSI | M34-A (Replaces M24-P) | Western Blot Assay for Antibodies to Borrelia burgdorferi; Approved Guideline. |
10/04/2010 | InVitro Diagnostics | 7-212 | Complete | CLSI | EP18-A2 | Risk Management Techniques to Identify and Control Laboratory Error Sources; Approved Guideline - Second Edition |
07/15/2019 | InVitro Diagnostics | 7-288 | Complete | CLSI | M24 3rd Edition | Susceptibility Testing of Mycobacteria, Nocardiae and other Aerobic Actinomycetes |
12/23/2019 | InVitro Diagnostics | 7-295 | Complete | CLSI | M52, 1st ed. August 2015 (Reaffirmed: January 2020) | Verification of Commercial Microbial Identification and Antimicrobial Susceptibility Testing Systems. |
12/23/2019 | InVitro Diagnostics | 7-293 | Complete | CLSI | QMS01, 5th ed. June 2019 (Replaces QMS01-A4) | A Quality Management System Model for Laboratory Services. |
01/14/2019 | InVitro Diagnostics | 7-232 | Complete | CLSI | MM05-A2 Vol. 32 No. 6 Replaces MM05-A Vol. 23 No. 17 | Nucleic Acid Amplification Assays for Molecular Hematopathology; Approved Guideline - Second Edition |
06/07/2021 | InVitro Diagnostics | 7-307 | Complete | CLSI | POCT05 2nd Edition | Performance Metrics for Continuous Interstitial Glucose Monitoring |
01/14/2019 | InVitro Diagnostics | 7-139 | Complete | CLSI | QMS24, 3rd Edition September 2016 Replaces GP27-A2 and GP29-A2 | Using Proficiency Testing to Improve the Clinical Laboratory; Approved Guideline - Second Edition |
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