Recognized Consensus Standards: Medical Devices
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1 to 10 of 115 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) |
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. |
03/18/2009 | InVitro Diagnostics | 7-180 | Complete | CLSI | M34-A (Replaces M24-P) | Western Blot Assay for Antibodies to Borrelia burgdorferi; Approved Guideline. |
07/15/2019 | InVitro Diagnostics | 7-288 | Complete | CLSI | M24 3rd Edition | Susceptibility Testing of Mycobacteria, Nocardiae and other Aerobic Actinomycetes |
12/21/2020 | InVitro Diagnostics | 7-300 | Complete | CLSI | MM13 2nd Edition | Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods |
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 |
12/21/2020 | InVitro Diagnostics | 7-299 | Complete | CLSI | POCT14 2nd Edition | Point-of-Care Coagulation Testing and Anticoagulation Monitoring |
03/18/2009 | InVitro Diagnostics | 7-170 | Complete | CLSI | I/LA21-A2 | Clinical Evaluation of Immunoassays; Approved Guideline - Second Edition |
03/18/2009 | InVitro Diagnostics | 7-176 | Complete | CLSI | I/LA30-A (Replaces I/LA30-P) | Immunoassay Interference by Endogenous Antibodies; 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 |
06/07/2021 | InVitro Diagnostics | 7-306 | Complete | CLSI | EP06 2nd Edition | Evaluation of the Linearity of Quantitative Measurement Procedures |
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