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U.S. Department of Health and Human Services

Product Classification

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Device microbial nucleic acid storage and stabilization device
Definition Molecular transport media is a device intended for the stabilization and transportation of nucleic acids from unprocessed human samples suspected of containing infectious material.
Physical State Liquid media.
Technical Method Media stores and stabilizes microbial nucleic acids.
Target Area Human samples.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeQBD
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Division of Microbiology Devices (DMD)
Submission Type 510(k)
Regulation Number 866.2950
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
Third Party Review Not Third Party Eligible
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