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U.S. Department of Health and Human Services

Product Classification
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Device system, nucleic acid amplification, mycobacterium tuberculosis complex
Review Panel Microbiology
Product CodeMWA
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Draft Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: Nucleic Acid-Based In Vitro Diagnostic Devices for the Detection of Mycobacterium tuberculosis Complex in Respiratory Specimens
Third Party Review Not Third Party Eligible
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