Name: CLSI MM22 A : 1ED 2014
Brand: CLSI

CLSI MM22 A : 1ED 2014

Superseded

View Superseded by

MICROARRAYS FOR DIAGNOSIS AND MONITORING OF INFECTIOUS DISEASES

Superseded date

01-31-2024

Published date

08-25-2018

Publisher

Clinical Laboratory Standards Institute

Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
3 Standard Precautions
4 Terminology
5 General Considerations in Developing Micoarrary Assays
6 Platform Overview
7 Clinical Applications
8 Assay Performance Verification and Validation
9 Quality Control and Quality Assurance
10 Data Analysis and Interpretation
References
The Quality Management System Approach
Related CLSI Reference Materials

Gives guidance for the laboratory development and use of qualitative nucleic acid microarray methods for the diagnosis and monitoring of infectious diseases.

DocumentType	Miscellaneous Product
PublisherName	Clinical Laboratory Standards Institute
Status	Superseded
SupersededBy	CLSI MM22:2024

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ANSI/AAMI/ISO 16142-2:2017	MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS
CLSI MM21 : 1ED 2015	GENOMIC COPY NUMBER MICROARRAYS FOR CONSTITUTIONAL GENETIC AND ONCOLOGY APPLICATIONS
BS ISO 16142-2:2017	Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards

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