Product code SES— Hematology
ConcizuTrace ELISA
- Classification name
- Non-Factor Replacement Product Test System
- Device class
- Class 2
- Regulation
- 21 CFR 864.7298
- Advisory panel
- Hematology
- Total cleared
- 1
- First cleared
- Most recent
FDA classification 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 context for product code SES
FDA has cleared device under product code SES, all in 2025, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code SES
Recent clearances under product code SES
Data sourced from openFDA. This site is unofficial and independent of the FDA.