FDA product code OYE

Flow Cytometric Reagents And Accessories.

Hematology·Class 2·21 CFR 864.5220
US regulatory classifications
US Product Code (FDA)
OYE
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 864.5220
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Medical specialty
Hematology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Eligible
Definition

To identify and classify cells or other particles in suspension by their inherent physical properties or associated fluorescent molecules in order to provide information about the distribution or number cells in suspension or their level of protein expression. These characteristics may aid in the diagnosis of conditions such as immunodeficiency and cancer.

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About this record

Flow Cytometric Reagents And Accessories. is a medical device type in the Hematology 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.