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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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1999 Biological Device Application Approvals

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


Tradename Description and Indication for Device Applicant Number Approval Date
Citroflex Plasticized PVC Extended Storage Platelet Bag Empty containers to be used with the MCS+ (LN9000) Apheresis System Platelet Collection Protocols Haemonetics Corp
400 Wood Road
Braintree, MA 02184
BK980040 1/7/1999
CytoTherm J Blood and Plasma Warning Devices Photo-Therm
110 Sewell Avenue
Trenton, NJ 08610
BK980042 1/7/1999
Cord-X System Empty containers to aid in the collection of umbilical cord blood samples Talon Medical, Ltd
18160 Highway
281 North Suite 108
San Antonio, TX 78232
BK980021 1/20/1999
BIOTEST DRB-ELPHA Low Resolution (Enzyme Linked Probe Hybridization Assay) Enzyme linked probe hybridization assay kit for low resolution determination of HLA-DRB alleles Biotest Diagnostics Corp
66 Ford Road, Suite 131
Denville, NJ 07834
BK980007 1/26/1999
Safe Trace TX, Ver 1.0 Blood establishment computer software Wyndgate Technologies
11060 White Rock Road
Suite 200
Rancho Cordova, CA 95670
BK980023 1/29/1999
ProCOUNT Software Software program for use with ProCOUNT reagents for flow cells, and percent CD34+ cells of nucleated cells cytometric identification and enumeration of CD34+ cells, percent CD34+ cells of CD45+ cells Becton Dickinson Immunocytometry Systems
2350 Qume Drive
San Jose, CA 95131
BK970038 2/4/1999
CryoSeal System Automated rapid preparation of Cryoprecipitated AHF Thermogenesis
3146 Gold Camp Drive
Suite 206
Rancho Cordova, CA 95670-6022
BK960072 2/12/1999
Status Symbol TM II System Software Blood establishment computer software Organon Teknika Corp
100 Akzo Ave
Durham, NC 27712
BK960026 3/16/1999
MEDITECH Blood establishment computer software MEDITECH Medical Information Technology, Inc
MEDITECH Circle
Westwood, MA 02090
BK960029 3/19/1999
Transfer/Freezing Bag Set Empty containers for the collection, manual processing, and freezing of blood components MEDSEP Corp
330 Turnbull Canyon Road
City of Industry, CA 91745
BK980027 3/26/1999
ACCURUN155 Quality control kits for blood banking reagents Boston Biomedia Inc
375 West Street
West Bridgewater, MA 02379
BK970004 4/23/1999
Vista Blood Bank Software Ver. 5.2 Blood establishment computer software Department of Veterans Affairs
P.O. Box 5000
VA Hines Medical Center
Hines, IL 60141
BK970021 4/23/1999
GTI PAT HPA-1 (PI) Genotyping Kit DNA-based kit used to genotype HPA-1 (PI), a platelet specific alloantigen system using PCR and ELISA Genetic Testing Institute
150 N. Patrick Blvd
Brookfield, WI 53045
BK980005 4/23/1999
Plasma Center Module 1.0 Blood Establishment Computer Software Fifth Dimension Information Systems
Suite 500
Midland Walwyn Tower
Edmonton Centre
Edmonton, CANADA
BK980025 5/18/1999
HemaSure r/LS Pre-Storage Leukoreduction Filtration System for Red Blood Cells
HemaSure r/LS Pre-Storage Leukoreduction Filtration System with Spike for Red Blood Cells
Blood Transfusion Microfilters used for leukocyte reduction from red blood cells prior to storage Hemasure, Inc
140 Locke Drive
Marlborough, MA 01752
BK980014 5/27/1999
VACUTAINER Brand PLUS (Plastic) Blood Collection Tube with EDTA Anticoagulant Blood specimen collection device (vacuum) used for the collection of venous blood for laboratory testing including immunohematology tests Becton Dickinson Vacutainer Systems
1 Becton Drive
Franklin Lakes, NJ 07417
BK980011 6/7/1999
SliDe Chek Quality control kits for blood banking reagents used to control the Anti-D Slide Test Biopool International,Inc
1230 Wilson Drove
West Chester, PA 19380-4254
BK980035 6/11/1999
Medusa 2000 Srimport, Ver. 1.2 Blood establishment computer software Sanguin International
1020 Sherman Ave
Hamden, CT 06514
BK980039 6/11/1999
ABBOTT PRISM System Automated bloodborne pathogen test equipment used to test donor bloodborne pathogens Abbott Laboratories
100 Abbott Park Road
Abbott Park, IL 60064-3500
BK970042 6/14/1999
StatusFlow Pro Automated differential cell counter used for CD 34+ whole blood process control for flow cytometry R & D Systems, Inc
614 McKinley Place, N.E.
Minneapolis, MN 55413
BK990005 6/21/1999
Isolex 300 & 300i Magnetic Cell Selection System Processing autologous peripheral blood progenitor cell (PBPC) products to obtain a CD 34+ cell enriched population intended for hematopoietic reconstitution after myeloablative therapy with CD 34-negative tumors Nexell Therapeutics, Inc
9 Parker
Irvine, CA 92718-1605
BP970001 7/2/1999
Biomixer 330 & Biomixer 323 Blood mixing and weighing devices used for blood collection and data registration Ljungberg & Kogel
c/o Kamm & Associates
P O Box 7007
Deerfield, IL 60015
BK990013 7/7/1999
Cell Wash/Infusion Bag Set Empty containers used for the collection and processing of blood and blood components MEDSEP Corp
330 Turnbull Canyon Road
City of Industry, CA 91745
BK980038 7/13/1999
Sepacell Pre-Storage Leukocyte Reduction Set for Red Cells Leukocyte reduction of one unit of Red Blood or Whole Blood Baxter Healthcare Corp
Route 120 and Wilson Road
Round Lake, IL 60073
BK980041 7/16/1999
HemoFlow Donor Monitor Blood mixing and weighing device used for blood bank donation weighing and monitoring Applied Sciences, Inc
964-B Golden Gate Terrace
Grass Valley, CA 95945
BK990011 7/16/1999
DACS-SC (Buoyant Density Solution 60) Buoyant density solution formulated for processing autologous mobilized peripheral blood progenitor cells (PBPC) collected by leukapheresis to reduce red blood cells, platelets and granulocytes in the final PBPC product Dendreon Corp
3005 First Avenue
Seattle, WA 98102
BK970003 7/23/1999
FlowPRA Screening test for use in flow cytometric detection of HLA-specific antibodies in serum One Lambda, Inc
21001 Kittridge St
Canoga Park, CA 91303
BP980015 7/23/1999
LifeTec 2.20 Blood Establishment Computer Software SysTec Computer Associates, Inc
28 North Country Road
Mt. Sinai, NY 11766
BK990003 7/30/1999
Flexilab 5.2 Blood Establishment Computer Software Sunquest Information Systems, Inc
4801 Broadway Blvd
Tuscon, AZ 85711
BK990002 8/16/1999
Surround System 1.0 Blood Establishment Computer Software Information Data Management, Inc
9701 West Higgins Road
Rosemont, IL 60018
BK990016 8/27/1999
Donor Management
System 1.0.0
Blood Establishment Computer Software Fifth Dimension Information Systems
Suite 500
Merril Lunch Tower
Edmonton Centre
Edmonton, Alberta
CANADA
BK990022 9/10/1999
Aurora / Fenestra
(Vers. 1.0) 1.0
Blood Establishment Computer Software - Virus Application used to screen blood donations for infectious diseases and immunohematology tests Sanguin International
1020 Sherman Ave
Hamden, CT 06514
BK980003 9/29/1999
HemoFlow Donor Monitor and Mixer Blood mixing and weighing devices used to monitor the flow of blood into the collection bag and to give a clear indication to the technician when the collection is completed and avoid overbleeds Applied Sciences, Inc
964-B Golden Gate Terrace
Grass Valley, CA 95945
BK990019 10/5/1999
Hot Shot FluidWarmer
Model 100; Model 101; Model 102; and Model 103
Blood and plasma device used to warm blood and blood products Infra-Med Technologies, Inc
5580 Peterson Lane, Suite 200
Dallas, TX 75240
BK990018 10/13/1999
Plasma Center Management System (PCMS) Ver. 1.2 Blood Establishment Computer Software Information Data Management, Inc
9701 West Higgins Road
Rosemont, IL 60018
BK990029 10/13/1999
LifeTrak/Distribution 2.03 Blood Establishment Computer Software Carter BloodCare
2205 Highway 121
Bedford, TX 76021
BK990015 10/22/1999
Rubin & Poor Configurable Manual Blot System 1.0C Blood Establishment Computer Software Rubin & Poor, Inc
150 West 25th St
Suite 600
New York, NY 10001
BK990008 10/29/1999
HNA Millennium PathNet Blood Bank Transfusion Blood Establishment Computer Software Cerner Corp
2800 Rock Creek Parkway
Kansas City, MO 64117-2551
BK990007 11/2/1999
Plasma Procurement Information System (PPIS) Ver. 3.0 Blood Establishment Computer Software Bayer Corp
800 Dwight Way
Berkeley, CA 94701-1986
BK990024 11/3/1999
FlexiLab Blood Bank and Blood Donor System Ver. 5.2 Blood Establishment Computer Software Sunquest Information Systems, Inc
4801 Broadway Blvd
Tucson, AZ 85711
BK990034 11/17/1999
Plasma Procurement Information System (PPIS) Ver. 4.0 Blood Establishment Computer Software Bayer Corp
800 Dwight Way
Berkeley, CA 94701-1986
BK990037 11/17/1999
MTS Reader M Blood Establishment Computer Software Micro Typing Systems Inc
1295 SW 29th Ave
Pompano Beach, FL 33069
BK990012 11/19/1999
Lymphoscreen ABC 60 HLA typing trays used for the determination of HLA-ABC specific antibodies by the lymphocytotoxicity test Biotest Diagnostics Corp
66 Ford Road, Suite 131
Denville, NJ 07834
BK980033 12/15/1999
Lymphoscreen DR 30x2 HLA typing trays used for the detection of HLA antibodies (HLA DR/DQ) Biotest Diagnostics Corp
66 Ford Road, Suite 131
Denville, NJ 07834
BK980044 12/15/1999
LikeTrak/Donor 2.03 Blood establishment computer software Carter BloodCare
2205 Highway 121
Bedford, TX 76021
BK990027 12/15/1999
Total Containment Device Use of a larger size tubing, 4.3 O.D. PVC, with the Total Containment Device DENCO, Inc
P.O. Box 9600
Wilmington, DE 19809
BK990041 12/21/1999