CLSI M48-A 2nd Edition Medical Standard

Laboratory Detection And Identification Of Mycobacteria

M48-A 2nd Edition

Standard Organization: CLSI

CLSI M48-A 2nd Edition
Laboratory Detection and Identification of Mycobacteria

Recognition Number

InVitro Diagnostics

Recognition Date

2019-01-14

Recognition List

051

Recognition Number

7-285

Extent

Complete standard

Standards Orgs

CLSI Clinical Laboratory Standards Institute https://clsi.org/

STG

InVitro Diagnostics

FDA Tech

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Rationale:

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Scope:

This standard addresses topics related to the laboratory diagnosis of mycobacterial infections including safety and related issues, levels of service and referrals, clinical significance of mycobacteria, acceptable specimen types and their collection, transport and storage, specimen processing methods, methods for the direct detection of mycobacteria in clinical specimens, culture methods including contamination issues, reporting and quality control, and phenotypic and genotypic identification procedures.

Code of Federal Regulations:

Regulation Number

Device Name

Device Class

Product Code

§866.3370

Antiserum, Fluorescent, Mycobacterium Tuberculosis

Class 1

GRT

§866.3370

Assay, Nucleic Acid Amplification, Growth Identification, Mycobacterium Tuberculosis

Class 1