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 |