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U.S. Department of Health and Human Services

Product Classification

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Device reagent/device, inoculum calibration
Regulation Description Antimicrobial susceptibility test powder.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeLIE
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.1640
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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