Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis
Medical specialty
Clinical Chemistry
Device class
1
Regulation number
862.2750
Review panel
CH
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Eligible
Definition
Flow cytometer specimen processors are automated or semi-automated workstations designed to be used alone or in combination with manual methods to pipette, dilute and process human specimens in preparation for flow cytometric analysis.