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U.S. Department of Health and Human Services

Product Classification

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Device culture media, antimycobacteria, susceptibility test
Regulation Description Culture medium for antimicrobial susceptibility tests.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeMJD
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.1700
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
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