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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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SOLX® System

NDA Number: BN110059
Product name: SOLX® System (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 “SOLX® System” 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.

 

 

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002