Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis
PER · Class I — Low Risk (general controls) · Clinical Chemistry · 21 CFR 862.2750
Classification
FDA Product Code
PER
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 862.2750
Review panel
CH
Medical specialty
Clinical Chemistry
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.