CLSI M48-A 2nd Edition

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 NumberInVitro Diagnostics
Recognition Date2019-01-14
Recognition List051
Recognition Number7-285
Extent Complete standard
Standards Orgs CLSI Clinical Laboratory Standards Institute https://clsi.org/
STG InVitro Diagnostics
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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 NDZ
§866.3370 Dna-Reagents, Mycobacterium Spp. Class 1 LQF
§866.3370 System, Mycolic Acid Analysis, Mycobacterium Tuberculosis Class 1 NJO
§866.2660 Kit, Identification, Mycobacteria Class 1 JSY

FDA Guidance:

Recognized Consensus Standards

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U.S. Department of Health and Human Services

Recognized Consensus Standards

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