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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device culture plate imaging system for qualitative assessment of resistant organisms
Regulation Description Automated image assessment system for microbial colonies on solid culture media.
Definition Culture plate imaging system for qualitative assessment of resistant organisms is an automated system to assess the presence or absence of colony growth on solid chromogenic culture media.
Product CodeQQY
Regulation Number 866.2190
Device Class 2


Premarket Reviews
ManufacturerDecision
BD KIESTRA B.V.
  SUBSTANTIALLY EQUIVALENT 1
CLEVER CULTURE SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1

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