ORL — Whole Blood Pre-Treatment T-Cell Enrichment Reagent Class III
FDA product code ORL covers "Whole Blood Pre-Treatment T-Cell Enrichment Reagent", a Class III medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- ORL
- Device Class
- Class III
- Regulation Number
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Unknown
- Implant
- No
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).