System, Microbial Growth Monitor Of Normally Sterile Body Fluid Culture
Medical specialty
Microbiology
Device class
1
Regulation number
866.2560
Review panel
MI
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
Definition
Qualitative, in vitro diagnostic system that monitors microbial growth directly from normally sterile body fluid sample incubated in a liquid culture medium