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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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1997 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
Biotest High Resolution Supplementary Kit Kit for HLA-DRB typing by oligonucleotide probe detection system Biotest Diagnostics Corp
66 Ford Road, #131
Denville, NJ 07834
BK960086 2/6/1997
Jewett Model CT1 Refrigerator/freezer to store blood and blood components between 2 and 4 degrees C Jewett Refrigerator Co, Inc
2-18 Letchworth St.
Buffalo, NY 14213
BK960089 2/6/1997
Micro Ssp HLA Class II DNA Typing Kit Leukocyte Typing Test One Lambda, Inc
21001 Kittridge Street
Canoga Park, CA 91303
BK960062 2/21/1997
NBCS 1.1 Stand Alone Blood Bank Software American Red Cross
Washington, DC 20006
BK960040 2/28/1997
Alton Dean Fluid Warmer, FW-337 Blood and Plasma Warming Devices Mallinckrodt Medical, Inc
675 McDonnell Blvd
St. Louis, MO 63134
BK960075 2/28/1997
Hematype Segment Device Blood Bank Supplies Medical Safety Product
2751 W. Oxford Ave., #5
Englewood, CO 80110
BK960083 2/28/1997
National Donor Deferral Registry Blood Bank Software American Blood Resources Association
Annapolis, MD 21404
BK960030 3/20/1997
HemoMatic Blood Collection Monitor Monitor whole blood collection from human donors Thermogenesis
Rancho Cordova, CA 95742
BK960074 4/3/1997
Donor Information System, Vers.1.0 Receive, analyze, and store data during collection Community Bio-Resources, Inc
Hoover, AL 35244
BK970007 4/9/1997
MCS+ Apheresis System (LN831 & LN833) Two Unit Allogeneic Red Blood Cell ollection Collection of two Red Blood Cells from single donors Haemonetics Corp
Braintree, MA
BK960095 4/11/1997
SAFETRACE Blood Bank Software Wyndgate Technologies
Rancho Cordova, CA 95670
BK950059 4/14/1997
MCS+ Red Blood Cell & Plasma Apheresis Set-Dry (LN822) Collect and store 1 unit of Red Blood Cells and up to 550 mL of plasma Haemonetics Corp
Braintree, MA 02184
BK960023 4/16/1997
MCS+ Red Blood Cell & Plasma Apheresis Set-Dry (LN823)Autologous Use Only Collect and store two Red Blood Cell concentrates Haemonetics Corp
Braintree, MA 02184
BK960022 4/16/1997
Jewett Model CTF-1 Blood Component Storage Jewett Refrigerator Co, Inc
Buffalo, NY 14213-1098
BK970001 4/16/1997
Gamma-ReACT Workstation Device to hold test strips and conventional test tubes Gamma Biologicals
Houston, TX 77092
BK970002 5/30/1997
Gamma-ReACT Reader Blood grouping viewer to examine and interpret test results Gamma Biologicals
Houston, TX 77092
BK970003 5/30/1997
Hemagglutination/Dilution Strips Automated Blood Grouping & Test System ABO/Rh Typing Immucor, Inc
Norcross, GA 30071
BK960016 6/4/1997
Capture-R Control Cells Quality Control Kits for Blood Bank Reagents Coombs Control Cells for use with ABS2000 only Immucor, Inc
Norcross, GA 30071
BK960020 6/4/1997
Olympus PK-TP System Control Set Quality Control Kits for Blood Banking Reagents Controls for Olympus PK-TP test for syphilis SCIMEDX, Corp
Denville, NJ 07834
BK960070 6/19/1997
Terumo Phlebotomy Needle Cap Holder Allows replacement of needle cap cover on used needle Terumo Medical Corp
Elkton, MD 21921
BK970011 6/19/1997
Biotest High Resolution Supplementary Kit HLA HLA-DRB typing by oligonucleotide probe detection system Biotest Diagnostics Corp
Denville, NJ 07834
BK960086 7/3/1997
Lambda Antigen Tray Leukocyte Typing Tray HLA Typing One Lambda Inc
Canoga Park, CA 91303
BK960011 7/3/1997
COBE Spectra LRS Turbo System Automated Blood Cell Separators Increased platelet collection COBE BCT
Lakewood, OH 80215
BK960076 7/14/1997
MCS+ Apheresis System Automated Blood Cell Separators Collection of 2 RBCs from a single donor Haemonetics Corp
Braintree, MA 02184
BK960095 7/14/1997
Nover Trip Scale Alarm Blood Mixing and Weighing Devices To increase safety of collections Tahoe Chemical R&D
Carson City, NV 89701
BK970012 7/14/1997
Pathnet Blood Center
(L-2510) Vers. 306 Standalone Blood Bank Software
Blood Bank Software Cerner Corp
Kansas City, KS 64117
BK950051 7/16/1997
Pathnet Blood Transfusion (L-2300) Vers. 306 Standalone Blood Bank Software Blood Bank Software Cerner Corp
Kansas City, KS 64117
BK950053 7/16/1997
Pathnet Blood Bank Donor (L-2400) Vers. 306 Standalone Blood Bank Software Blood Bank Software Cerner Corp
Kansas City, KS 64117
BK950055 7/16/1997
Pathnet Work-system Bank Transfusion
(L-2812) Vers. 306 Standalone Blood Bank Software
Blood Bank Software Cerner Corp
Kansas City, KS 64117
BK960024 7/16/1997
Jewett Model BBWM3 Blood Storage Refrigerators and Freezers To store blood and blood components between 2-4 degrees Centigrade Jewett Refrigerator Co, Inc
Buffalo, NY 14213
BK970014 7/18/1997
Jewett Model CTF-1 Blood Storage Refrigerators and Freezers To store blood and blood components between 2-4 C Jewett Refrigerator Co, Inc
Buffalo, NY 14213
BK960089 7/18/1997
Gamma EGA Kit Potentiating Media for in vitro Diagnostic Use For removal of IgG from coated RBCs to enable them to be tested for their surface antigens by indirect antiglobulin tests Gamma Biologicals, Inc
Houston, TX 77092
BK960090 7/21/1997
ABS QC Test System/ABS QC Plus Quality Control Kits for Blood Banking Reagents Test System For daily QC of blood banking reagents for ABS2000 only Immucor, Inc
Norcross, GA 30071
BK960018 7/21/1997
Defense Blood Standard System (DBSS), Ver. 1.0/1.03 Standalone Blood Bank Software Dept of Defense
Falls Church, VA 22047-3606
BK960004 8/1/1997
Biotest DQB-ELPHA Leukocyte typing tray for phenotyping human white cells Biotest Diagnostics Corp
Denville, NJ 07834
BK960061 8/4/1997
CryoGuard Thermal Exposure Indicator Blood bank supplies used for signaling thermal exposure at various degrees Controlled Chemicals, Inc
Ann Arbor, MI 48104
BK970010 8/26/1997
Samplink Blood bank supplies for safe blood sampling in closed system at end of donation process MIGADAS INC
Englewood Cliffs, NY 07632
BK970022 9/18/1997
Gamma-ReACT Centrifuge Rapid centrifugation of Gamma-ReACT strips for Immunohematology Gamma Biologicals, Inc
Houston, TX 77092
BK960077 9/18/1997
Gamma-ReACT Incubator Blood bank supplies designed to incubate 10 Gamma-ReACT strips Gamma Biologicals, Inc
Houston, TX 77092
BK960078 9/18/1997
Gamma-ReACT Antibody Detection Strips New technology for performing antibody detection, antibody identification, and compatibility testing Gamma Biologicals, Inc
Houston, TX 77092
BK960079 9/18/1997
Gamma-ReACT Diluent Potentiating media for use in in vitro diagnostics Gamma Biologicals, Inc
Houston, TX 77092
BK960080 9/18/1997
Gamma-ReACT Control Cells (EigG) Control kit for confirmation of negative test results in Gamma-ReACT Gamma Biologicals, Inc
Houston, TX 77092
BK960081 9/18/1997
MCS+ Double Unit RBC Apheresis Set-Dry (LN832) System (Autologous Use Only) Apheresis Collection Set with RBC Storage Bag to collect and store 2 Red Blood Cells Concentrate Haemonetics Corp
Braintree, MA 02184
BK960022 9/18/1997
VIROTROL II Quality control kits for Blood Banking - Used as a quality control serum with assay procedures for determination of antibodies to HBsAg & HAV Blackhawk BioSystems, Inc
San Ramon, CA 94583
BK960085 10/3/1997
Jewett Model BPL55 Blood storage refrigerators and freezers for plasma storage Jewett Refrigerator Co
Buffalo, NY 14213-1098
BK970028 10/15/1997
Blood Bank Control System Standalone blood bank software Blood Bank Computer Systems, Inc
Auburn, WA 98001
BK960044 10/15/1997
Capture S Syphilis Antibody Screen Immucor, Inc
Norcross, GA 30071
BK950017 10/24/1997
CBC Blood System Vers. 1.2 Standalone Blood Bank Software Community Blood Center of Greater Kansas City
Kansas City, MO
BK960060 11/20/1997
RC12BP Blood bank centrifuges for in vitro diagnostic use Sorvall, Inc
Newton, CT
BK970032 12/5/1997
SMS Blood Bank Transfusion Systems, Vers. 2.0, 3.0, 4.0 Blood establishment computer software Shared Medical Systems
Malvern, PA 19355
BK960036 12/12/1997
Transfusion Service Manager Vers. 4.1.6 Blood establishment computer software Dynamic Healthcare
Technologies, Inc
Maitland, FL 32751
BK960041 12/16/1997