SES

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Non-Factor Replacement Product Test System

Device class

Class II (moderate risk)

Regulation

21 CFR 864.7298

Medical specialty

Hematology

FDA 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.

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