U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Vaccines, Blood & Biologics
  3. Blood & Blood Products
  4. Approved Blood Products
  5. SOLX System
  1. Approved Blood Products

SOLX System

NDA Number: BN110059
Product name: SOLXSystem (LEUKOSEP HWB-600-XL Leukocyte Reduction Filtration System for Whole Blood with CPD Anticoagulant and SOLX Additive)
Manufacturer: Hemerus Medical, LLC
Indication: The LEUKOSEP® HWB-600-XL Leukocyte Reduction Filtration System for Whole Blood with CPD Anticoagulant and SOLX® Additive also called “SOLXSystem” is intended for the manufacture of:

  • CPD/AS-7 Red Blood Cells (RBC), Leukocytes Reduced prepared at ambient temperature and placed at 1 to 6° C within 8 hours of collection. CPD/AS-7 Red Blood Cells, Leukocytes Reduced may be stored at 1 to 6° C for up to 42 days after collection.
  • Fresh Frozen Plasma (FFP), Leukocytes Reduced prepared and placed in a freezer at -18° C or colder within 8 hours of collection. Fresh Frozen Plasma (FFP), Leukocytes Reduced may be stored at -18° C or colder for up to one year after collection.

Product Information

Supporting Documents

 
Back to Top