Whole Blood Pre-Treatment T-Cell Enrichment Reagent

ORL · Class III — High Risk (PMA approval required, life-sustaining) · Unknown

Classification

FDA Product Code: ORL
Device class: Class III — High Risk (PMA approval required, life-sustaining)
Regulation: —
Review panel: MI
Medical specialty: Unknown
Submission type: 2
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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).

Market data

Cleared 510(k) submissions: 0
Registered establishments: 0

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown