In the United States, “The SOLX™ System”, is FDA Approved and indicated for:
- Pre-storage leukocyte reduction of CPD whole blood followed by preparation of AS-7 Red Cells, Leukocytes Reduced, prepared at room temperature and placed at 1 – 6° C within 24 hours of collection. AS-7 Red Cells, Leukocytes Reduced, may be stored at 1 – 6° C for up to 42 days after collection.
- Pre-storage leukocyte reduction of CPD whole blood held at 1 – 6° C and preparation of AS-7 Red Cells, Leukocytes Reduced, within 72 hours after collection. AS-7 Red Cells, Leukocytes Reduced, may be stored at 1 – 6° C for up to 42 days after collection.
- Preparation of Fresh Frozen Plasma (FFP), Leukocytes Reduced prepared from a whole blood collection and frozen at -18° C or below within 8 hours of collection. FFP, Leukocytes Reduced may be stored at -18° C or colder for up to one year after collection.
- Preparation of Plasma Frozen Within 24 Hours After Phlebotomy (PF24), Leukocytes Reduced prepared from a whole blood collection. The product can be held at room temperature (RT) up to 8 hours after collection, refrigerated at 1 – 6° C until separated, and placed at -18° C or below within 24 hours of whole blood collection. PF24, Leukocytes Reduced may be stored at -18°C or colder for up to one year after collection.
- Preparation of Plasma Frozen Within 24 Hours After Phlebotomy Held at Room Temperature Up to 24 Hours After Phlebotomy (PF24RT24), Leukocytes Reduced prepared from a whole blood collection can be held at room temperature for up to 24 hours after collection, separated, and placed at -18° C or colder within 24 hours of collection. PF24RT24, Leukocytes Reduced may be stored at -18° C or colder for up to one year after collection.