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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 Division of Microbiology Devices (DMD)
Division of Microbiology Devices (DMD)
Submission Type 510(k)
Regulation Number 866.1700
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review
Accredited Persons
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