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.