FDA product code PER

Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis

Clinical Chemistry·Class 1·21 CFR 862.2750
US regulatory classifications
US Product Code (FDA)
PER
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US Risk Class (FDA)
Class 1
US Regulation (CFR)
21 CFR 862.2750
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Medical specialty
Clinical Chemistry
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not 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.

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About this record

Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis is a medical device type in the Clinical Chemistry specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.