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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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1998 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
Umbilicup II Cord Blood Collection System Container system for collection and processing of umbilical cord blood Utah Medical Products, Inc
Midvale, UT 84047
BK970027 1/6/1998
Alpha Plasma Pooling Bottle II (60-2227S) Container system for collection and processing of donor plasma by automated plasmapheresis Alpha Therapeutic Corp
Los Angeles, CA 90032
BK970029 1/7/1998
Medsep Plasma Bag (EVA Plastic) Plasma bag for collection and processing of donor blood and blood products Medsep Corp
City of Industry, CA 91745
BK970040 1/23/1998
ThermoStat 900 Blood and plasma warming device used to warm blood, plasma, and IV fluids to normothermic temperatures Microwave Medical System
Acton, MA 01720
BK970044 1/23/1998
Umbilicup Container system for collection of umbilical cord blood and transferring to vacuum tubes for laboratory analysis Utah Medical Products, Inc
Midvale, UT 84047
BK970026 1/28/1998
ViroSure Multi-Marker Quality control kit intended to be used with the EIA test systems for anti-HIV-1/2, anti-HBc, anti-HBsAg, anti-HCV, and anti-HTLV-1 North American Biologicals, Inc
16500 N.W. 15th Ave
Miami, FL 33169
BK960071 2/11/1998
Micro SSP HLA Class II DNA Typing Kit Leukocyte Typing Test One Lambda, Inc
21001 Kittridge St
Canoga Park, CA 91303
BK960062 2/11/1998
Donor-ID, Version 1.0 Blood establishment computer software Digi-Trax
1500 Barclay Blvd
Buffalo Grove, IL 60089
BK970013 2/27/1998
SegMed To transfer the contents of a segment into a test tube Teva Medical Ltd
482 Hudson Terrace
Englewood Cliffs, NJ 07632
BK980002 3/2/1998
ThermoStat 900 Blood & IV Fluid Administration Set Blood and plasma warming devices Microwave Medical System
310-312 School St
Acton, MA 01720
BK970045 3/6/1998
DoseWriter Blood establishment computer software CIS-US, Inc
10 de Angelo Drive
Bedford, MA 01730
BK960049 3/25/1998
Bloodpack Needle Protector (BNP) Used as an aid in prevention of accidental needle stick injuries upon completion of blood collection procedures ITL Corp, Ltd
22 Molonglo Mall
Fyshwick, Canberra 2609
AUSTRALIA
BK980008 4/7/1998
Gambro Hemofreeze Bag Empty containers for the collection and processing of human blood components NPBI
Runde ZZ 41, 7881 HM
Emmer Compascuum
NETHERLANDS
BK960084 5/28/1998
Terumo Sterile Tubing Welder SC-201A (TSCD) Provides a sterile weld between two pieces of polyvinyl chloride tubing Terumo Medical Corp
125 Blue Ball Road
Elkton, MD 21921
BK970008 5/28/1998
HLA-DR oligo detection kit Detection and differentiation of HLA Class II DNA Sequences for performing generic HLA-DR typing bioMerieux
1022 Hingham Street
Rockland, MA 02370-1052
BK970017 5/28/1998
ProCount Progenitor Cell Enumeration Kit An IVD test to identify and enumerate absolute counts and percentages of CD34+ cells in human peripheral blood samples, mobilized peripheral blood, and leukopheresis samples using flow cytometry Becton Dickinson Immunocytometry Systems
2350 Qume Drive
San Jose, CA 95131
BK960087 6/4/1998
Abbott Apheresis Results Tracking System (AARTS) Ver. 1 Blood establishment computer software Abbott Laboratories
100 Abbott Park
Abbott Park, IL 60064
BK950048 6/24/1998
ABS2000 Automated ABO/Rh typing, antibody detection compatibility test system Immucor, Inc
P.O. Box 5625
Norcross, GA 30091-5625
BK960019 6/30/1998
Modified Capture-R Used in the detection and identification of IgG antibodies to red cells Immucor, Inc
P.O. Box 5625
Norcross, GA 30091-5625
BK960017 6/30/1998
Lifeline Blood Bank Data Management System, Release 4.2 Blood establishment computer software Informedics, Inc
4000 Kruso Way Place
Bldg. 3, Suite 210
Lake Oswego, OR 97035
BK950064 7/1/1998
COBE Spectra Apheresis System Anticoagulant Free Flow Restriction Automated blood cell separators used to reduce the risk of injury due to anticoagulant free flow if a loss of anticoagulant pump tubing occurs COBE BCT
1201 Oak Street
Lakewood, CO 80215
BK980004 7/9/1998
SoftBank II, Ver. 19.1 Blood establishment computer software Soft Computer Consultants, Inc
34350 US Highway 19 North
Palm Harbor, FL 34684-2149
BK960033 7/10/1998
Lifetec Community Blood Center System, Rev. 2.10 Blood establishment computer software SysTec Computer Associates, Inc
738 Smithtown Bypass
Smithtown, NY 11787
BK960034 7/28/1998
Plasma Center Management System, Ver. 1.0 Blood establishment computer software Information Data Management, Inc
9701 West Higgins Road
Rosemont, IL 60018
BK980020 7/31/1998
PHIS Ver. 2.0 Blood establishment computer software Bayer Corp
800 Dwight Way
Berkeley, CA 94701-1986
BK960051 8/7/1998
ADAC Blood Bank System Blood establishment computer software ADAC HealthCare Information System
Houston, TX 77046
BK960027 8/12/1998
LeucoCOUNT Reagent Automated differential cell counter used in the enumeration of residual leucocytes in leucoreduced products Becton Dickinson Immunocytometry Systems
San Jose, CA 95131
BK970046 8/14/1998
Abbott DMS II Blood establishment computer software Abbott Laboratories
100 Abbott Park Road
Abbott Park, IL 60064-3500
BK950032 8/18/1998
Abbott Data Management System, Ver. 3.0.2 Blood establishment computer software Abbott Laboratories
Abbott Park, IL 60064-3500
BK950030 8/18/1998
STELLer CD24 Assay Automated differential cell counter used to determine the concentration of CD34+ cells in peripheral blood and apheresis products Biometric Imaging, Inc
Mountain View, CA 94043
BK970018 8/18/1998
Medsep Freezing Bag Empty containers for the collection of blood components for use in the freezing of blood components MEDSEP Corp
City of Industry, CA 91745
BK980030 8/29/1998
DBSS 3.00 Blood establishment computer software Department of Defense
Falls Church, VA 22041-3206
BK980031 8/31/1998
PCMS Ver. 1.1 Blood establishment computer software Information Data Management, Inc
9701 West Higgins Road
Rosemont, IL 60018
BK980028 9/4/1998
LN994CF Automated blood cell separators used to collect leukoreduced platelets and plasma by apheresis using the MCS+LN9000 Haemonetics Corp
400 Wood Road
Braintree, MA 021
BK970034 9/15/1998
CEQer RBC Assay Automated differential cell counter used to determine the concentration of whole blood cells in leukoreduced red blood cell components Biometric Imaging, Inc
1025 Terra Bella Avenue
Mountain View, CA 94043
BK970015 9/18/1998
CEQer PRP Assay Automated differential cell counter used to determine the concentration of residual whole blood cells in leukoreduced platelet rich plasma Biometric Imaging, Inc
1025 Terra Bella Avenue
Mountain View, CA 94043
BK970016 9/18/1998
LifeTrak/Lab(a.k.a. Lab*Care), Ver.2.01 Blood establishment computer software BloodCare
9000 Harry Hines Blvd
Dallas, TX 75235
BK980048 10/1/1998
Focussed System Automated blood component collection system COBE BCT
1201 Oak Street
Lakewood, CO 80215
BK970005 10/13/1998
Collection of pRBC Using the Focussed System Automated blood component collection system COBE BCT
1201 Oak Street
Lakewood, CO 80215
BK970023 10/13/1998
Ortho Summit System Blood establishment computer software Ortho Diagnostic Systems, Inc
U.S. Highway 202
Raritan, NJ 08869
BK960003 10/19/1998
Ortho Summit Processor Blood establishment computer software Ortho Diagnostic Systems, Inc
U.S. Highway 202
Raritan, NJ 08869
BK960052 10/19/1998
PAKAUTO Platelet Antibody Screening Kit Test kit used in the detection of platelet autoantibodies in eluates or serum/plasma Genetic Testing Institute
150 N. Patrick Blvd
Brookfield, WI 53045
BK960059 10/22/1998
CS-3000 Plus (Mononuclear Cells) Automated blood cell separator used for the collection of mononuclear cells from peripheral blood Baxter Healthcare Corp
1 Baxter Parkway
Deerfield, IL 60015
BK950013 10/28/1998
COBE Spectra Apheresis System Automated blood cell separator used for the collection of mononuclear cells from peripheral blood COBE BCT
1201 Oak St
Lakewood, CO 80215
BK950065 10/28/1998
Olympus PK CMV-PA System & Controls Automated blood grouping and anitbody test systems used in the qualitative detection of IgG & IgM antibodies to CMV in human plasma and serum from blood donors SciMedx TEKFILES Services
400 Ford Road
Denville, NJ 07834
BK960092 10/28/1998
ID-Tipmaster Blood bank supplies used in dispensing multiple deliveries of specified volumes of liquids (12.5, 25, abd 50 ul) Micro Typing Systems, Inc
1295 S.W. 29th Avenue
Pompano Beach, FL 33069
BK980016 10/29/1998
Coombs Control Cells(IgG Coated) Quality control kits for blood banking reagents Dominion Biologicals Ltd
5 Isnor Drive
Dartmouth, Nova Scotia
B3B1M1 Canada
BK980009 10/30/1998
Haemonetics Corp Extended Storage Platelet and Plasma Apheresis Set with Saline Compensation and Pall Leukoreduction Filter LRF-XL (LN994C) Automated Blood Cell Separators Haemonetics Corp
400 Wood Road
Braintree, MA 02184
BK970041 11/16/1998
PRA-STAT Anti-HLA CLASS I IgG Antibodies/Two Patients Per Plate Format Human Leukocyte Antigen (HLA) Typing Kit SangStat Medical Corp
1505-B Adams Drive
Menlo Park, CA 94025
BK970037 11/18/1998
Progesa, Ver. 4.4a Blood establishment computer software MAK-System
Z.I. Paris Nord II
13, Rue de la Perdix
B.P. 50035
95946 Roissy C.D.G. CEDEX, France
BK960050 12/10/1998
Hemocare Blood Bank Management System, Rev. 5.2 Blood establishment computer software Mediware Information Systems Inc
1121 Old Walt Whitman Rd
Melville, NY 11747
BK980034 12/10/1998
Olympus System Control Reagent Control reagent for blood grouping in the Olympus PK7200 Automated Microplate System Gamma Biologicals, Inc
3700 Mangum Rd
Houston, TX 77092
BK970047 12/11/1998
Sanguin Medusa 2000, Ver. 3.4 Blood establishment computer software Sanguin International
1020 Sherman Ave
Hamden, CT 06514
BK960065 12/17/1998
Bioaccess Marrow Collection System Bone marrow collection kit used to collect and filter bone marrow aspirate from a bone marrow harvest BioAccess, Inc
8400 Cedar St
Silver Spring, MD 20910
BK970035 12/23/1998