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 |