FDA-CLASS II NUCLEIC Class II Special Controls Guideline: Nucleic Acid-Based In Vitro Diagnostic Devices for the Detection of Mycobacterium tuberculosis Complex and Genetic Mutations Associated with Mycobacterium tuberculosis Complex Antibiotic Resistance in Respiratory Specimens - Guideline for Industry and Food and Drug Administration Staff

FDA-CLASS II NUCLEIC - 2014 EDITION - CURRENT



Class II Special Controls Guideline: Nucleic Acid-Based In Vitro Diagnostic Devices for the Detection of Mycobacterium tuberculosis Complex and Genetic Mutations Associated with Mycobacterium tuberculosis Complex Antibiotic Resistance in Respiratory Specimens - Guideline for Industry and Food and Drug Administration Staff


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Document Number

FDA-CLASS II NUCLEIC

Revision Level

2014 EDITION

Status

Current

Publication Date

Oct. 22, 2014

Page Count

37 pages