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.