Vaccines, Blood & Biologics

2018 Biological Device Application Approvals

This list reflects information regarding the applications as of the approval/clearance date. It is not updated with regard to applicant or application status changes. The applications are listed in order by date of approval / clearance in reverse chronological order.

2018 Biological Device Application Approvals
Tradename/Common Name Description and Indication for Device Submission ID Manufacturer Clearance Date
EVICEL™ Laparoscopic Airless Spray Accessory (35 cm Rigid)
Fibrin Sealant Preparation Device
The EVICEL™ Laparoscopic Airless Spray Accessory (35 cm Rigid) is intended to be used with the EVICEL™ Application Device for the simultaneous topical application of the two biological components of EVICEL® Fibrin Sealant (Human) onto the surface. BK170138/0 ETHICON Inc.
Route 22 West
Somerville, New Jersey 08876
UltraCW®II Automatic Cell Washing System
Automated cell-washing centrifuge for immune-hematology

The UltraCW®II Automatic Cell Washing System is intended to be used for the washing portion of routine blood bank and laboratory procedures calling for washed red blood cells such as antiglobulin testing, ABO compatibility, Rh, cross matching and anti-body screening.

The UltraCW®II Automatic Cell Washing System should be operated by a trained individual such as a clinical laboratory technologist or similar education as determining whether desired results have been achieved is subjective and is dependent upon user preparation of blood sample, and parameter selection/adjustment.

BK170141/0 Helmer Inc.
14400 Bergen Boulevard
Nobelsville, IN 46060
Procleix Xpress® System (Software v3.0)
Automated blood grouping and antibody test system
The Procleix Xpress® System (Software and Instrument) is intended to be used to create pools of human plasma or serum for blood screening tests for viral nucleic acids. The Procleix Xpress® System automatically transfers plasma or serum from individual samples into a single master pool tube, which may be used for further testing in Procleix® systems. The Procleix Xpress® System also collects barcode data from all tubes, racks, and archive plates used in a given pooling run, establishing positive specimen identification and Master Pool Tube (MPT) composition. In addition, the Procleix Xpress® System can be used to dispense human plasma or serum aliquots into an archive plate. BK170162/0 Grifols Diagnostic Solutions Inc.
4560 Horton Street
Emeryville, CA 94608
Cyclone Blood & Bone Marrow Concentration (BBMC) System
Platelet And Plasma Separator For Bone Graft Handling
The Cyclone Blood BBMC System is designed to be used intraoperatively at the point of care for the safe and rapid preparation of a platelet concentrate (platelet rich plasma or PRP) from a small sample of a mixture of peripheral blood and bone marrow. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect for improved handling characteristics. BK170108/0 Alliance Partners LLC
14206 Northbrook Drive
San Antonio, TX 78232


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