Product code ORL

Device name

Whole Blood Pre-Treatment T-Cell Enrichment Reagent

Medical specialty

Unknown

Device class

3

Review panel

MI

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

The reagent is for the pre-treatment of whole blood prior to lymphocyte separation. The reagent aids in the removal of selected white blood cells from whole blood stored at room temperature (18-25°C).

Source

FDA openFDA device classification dataset