# Non-Factor Replacement Product Test System
> **Product code: SES** · Class II — Moderate Risk (510(k) clearance required) · Hematology · 21 CFR 864.7298
## Classification
- **FDA Product Code:** SES
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 864.7298
- **Review panel:** HE
- **Medical specialty:** Hematology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

A non-factor replacement product test system is a prescription in vitro diagnostic device intended to measure non-factor replacement therapeutic products that are indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with bleeding disorders, including hemophilia, in human blood specimens to ensure appropriate therapy in accordance with the approved non-factor replacement product labeling.

## Market data
- **Cleared 510(k) submissions:** 1
- **Registered establishments:** 2
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=SES)
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