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U.S. Department of Health and Human Services

Product Classification

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Device culture media, propagating transport
Regulation Description Transport culture medium.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeJSN
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.2390
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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