# Flow Cytometric Reagents And Accessories.
> **Product code: OYE** · Class II — Moderate Risk (510(k) clearance required) · Hematology · 21 CFR 864.5220
## Classification
- **FDA Product Code:** OYE
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 864.5220
- **Review panel:** HE
- **Medical specialty:** Hematology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** Y
## 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.

## Market data
- **Cleared 510(k) submissions:** 8
- **Registered establishments:** 11
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=OYE)
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