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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, test, genotypic detection, resistant markers, staphylococcus colonies
Regulation Description Antimicrobial susceptibility test powder.
Product CodeMYI
Regulation Number 866.1640
Device Class 2

MDR Year MDR Reports MDR Events
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 2 2
Improper or Incorrect Procedure or Method 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2 2

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