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U.S. Department of Health and Human Services

Product Classification

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Device system,test,genotypic detection,resistant markers,staphylococcus colonies
Regulation Description Antimicrobial susceptibility test powder.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeMYI
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
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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