Culture Plate Imaging System For Qualitative Assessment Of Resistant Organisms
Medical specialty
Microbiology
Device class
2
Regulation number
866.2190
Review panel
MI
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
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.