Positive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing
Medical specialty
Microbiology
Device class
2
Regulation number
866.1650
Review panel
MI
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
Definition
Processing device that includes associated reagents, when applicable, that is intended to recover microbes from positive blood cultures for inoculum preparation. The prepared inoculum is intended for subsequent use in antimicrobial susceptibility testing.