Product code OYE

Device name

Flow Cytometric Reagents And Accessories.

Medical specialty

Hematology

Device class

2

Regulation number

864.5220

Review panel

HE

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

Y

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset