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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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1996 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
Blood Storage Refrigerator REB-2304 Blood Storage Refrigerator Revco/Lindberg
Asheville, NC 28804
BK950054 1/11/1996
Katzen Thrombolysis Guidewire Infusion Catheter Boston Scientific Corp
Place Natick, MA 01760-1537
BK940025 1/24/1996
COBE Spectra LRS Leuko-reduction System (Ver. 5) Automated Blood Cell Separator COBE BCT, Inc
Lakewood, CO 80215
BK950056 1/31/1996
Blood Storage Refrigerator
HLT-30V-4BB
Blood Storage Refrigerator Revco/Lindberg
Asheville, NC 28804
BK950066 1/31/1996
Cryocyte Freezing Container Blood Component Freezing Container Baxter Healthcare Corp
Irvine, CA 92718
BK950049 2/14/1996
Thermal Wave Blood and Plasma Thermer Thermal Transfer Technology
Placerville, CA 95667
BK950067 2/15/1996
Double Product Collection (SDP-3) Apheresis Hardware & Disposable Collection Sets Haemonetics Corp
Braintree, MA 02184
BK950034 2/15/1996
COBE Spectra Extended Life with Integrated Leukoreduction Filter Automated Blood Cell Separator Platelet Set COBE BCT
Lakewood, CO 80215
BK950030 2/15/1996
Cyto-Therm-S Plasma Thawer Photo-Therm
Trenton, NJ 08610
BK960012 4/15/1996
MTS Centrifuge Model #9310 Centrifuge Micro Typing Systems, Inc
Pompano Beach, FL 33069
BK960013 4/15/1996
Haemonetics PCS2 Apheresis Hardware and Disposable Collection Set Haemonetics Corp
Braintree, MA 02184
BK950033 4/16/1996
Confide HIV-Blood Testing Service Direct Access Diagnostics
Bridgewater, NJ 08807
BP900003 5/14/1996
[NONE] Cell Wash Set Baxter Healthcare
Irvine, CA 91203
BK960010 5/22/1996
OraSure HIV-1 Western Blot Kit HIV Sample Collection Kit Epitope Inc
Beaverton, OR 97005
BP950004 6/3/1996
Roche Amplicor HIV-1 Monitor Test HIV Monitor Test Roche Molecular Systems, Inc
Somerville, NJ
BK950005 6/3/1996
Olympus PK CMV System and System Controls Anti-CMV Kit Hemagen Diagnostics, Inc
Waltham, MA 02154
BK940035 7/15/1996
Fresenius AS104 Cell Separator Automated Blood Cell Separator Fresenius USA, Inc
Walnut Creek, CA 94598
BK980007 7/22/1996
Red Blood Cell & Apheresis Set #823 Apheresis Collection Set Haemonetics Corp
Braintree, MA 02184
BK950063 7/22/1996
Home Access HIV-1 Test System HIV Sample Collection Kit Home Access Health Corp
Hoffman Estates, IL 60195-5200
BP950002 7/22/1996
Jewett Models BPL13, BPL21,BPL25 Blood Storage Refrigerators and Freezers Jewett Refrigerator Co, Inc
Buffalo, NY 14213-1098
BK960054 8/8/1996
ACT Bouyant Density Solution Silanated Collodial Silica Supplemented with Polyvinynolidone Activated Cell Therapy, Inc
291 Bernardo Avenue
Mountain View, CA 94043
BK960002 8/12/1996
Components and Distribution Information System CDIS, Ver. 1.1 Blood bank software used to receive and store data in the testing, manufacturing, and distribution of blood and blood products Information Data Management, Inc
Rosemont, IL 60018
BK950037 8/26/1996
Donor Mgmt. Information Systems DMIS, Ver. 1.2 Blood bank software used to receive and store data in the testing, manufacturing, and distribution of blood and blood products Information Data Management, Inc
Rosemont, IL 60018
BK950045 8/26/1996
Eagle Series Blood Storage Refrigerator # ST30RGBB & ST50 Blood storage refrigerator Frigidaire Commercial Products Company
707 Robins St
Conway, AR 72032
BK960066 8/30/1996
CharterMed Transfer Bags Empty Blood Collection and Processing Containers CharterMed, Inc
Lakewood, NJ 08701
BK960043 9/11/1996
OPUS CMV Test for antibody to CMV Behring Diagnostics
175 University Ave
Westwood, MA 02090
BK960001 10/9/1996
Double Unit RBC Apheresis Set for the MCS+ List No. 833 Aheresis collection device to collect 2 units of red blood Haemonetics Corp
400 Wood Road
Braintree, MA 02184
BK960006 10/15/1996
Coombs Control Cells (EigG) Strong Quality control kit for blood banking reagents to verify negative Coombs test results Gamma Biologicals, Inc
3700 Mangum Road
Houston, TX 77092
BK960055 10/23/1996
Coombs Control Cells (EigG) Weak Quality control kit for blood banking reagents to verify negative Coombs test results Gamma Biologicals, Inc
3700 Mangum Road
Houston, TX 77092
BK960056 10/23/1996
Anti-B27 FITC/CD3PE Conjugated Monab Leukocyte typing tray to test leukocytes for B27 One Lambda, Inc
21001 Kittridge St
Canoga Park, CA 91303
BK960053 10/30/1996
Radtag Blood banking devices used to indicate blood was irradiated at appropriated range Indico, Inc
222 Campus Towers
8625 112th Street
Edmonton, ALBERTA T6G2E1
BK960068 10/30/1996
Models BBR17, BBR25m BBR36 and BBR55 Blood storage refrigerator and freezer to store blood and blood products Jewett Refrigerator Co, Inc
2-18 Letchworth Street
Buffalo, NY 14213-1098
BK960073 10/30/1996
Y-Type Rejuvenation Set - PN7212 Plastic Tubing for Fluid Transfer Cytosol Labs., Inc
55 Messina Drive
Braintree, MA 02184
BK950060 11/25/1996
CEPRATE SC Stem Cell Concentration System Device to process autologous bone marrow to obtain CD34+ cell enriched population CellPro, Inc
22215 26th Ave, S.E.
Bothell, WA 998021
BP940001 12/6/1996
Amicus Separator Automated Centrifugal Blood Cell Separator Blood Cell Separator Baxter HealthCare Corp
1 Baxter Parkway
Deerfield, IL 60015
BK960005 12/19/1996