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U.S. Department of Health and Human Services

Product Classification
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Device transport medium, notified per the vtm guidance
Regulation Description Transport culture medium.
Definition Notified transport media and collection devices intended for specimen collection and transport for use in detection of respiratory viruses including coronavirus per the guidance (Notified transport media and collection devices intended for specimen collection and transport for use in detection of respiratory viruses including coronavirus).
Physical State Liquid transport medium
Technical Method Transport medium for clinical upper respiratory specimens for viral diagnosis including COVID
Target Area Human clinical specimens
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeQMC
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Microbiology Devices (DMD)
Submission Type 510(k)
Regulation Number 866.2390
Device Class 1
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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