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 |