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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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2000 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
Plasma Center Management System (PCMS) Vers. 2.0 Blood Establishment Computer Software Information Data Management, Inc
9701 West Higgins Road
Rosemont, IL 60018
BK990046 1/6/2000
Accurun 106 HIV-1 Antigen Quality control kits for bloodborne pathogen testing of donors used with in vitro diagnostic tests for the detection of HIV-1 antigen Boston Biomedicia, Inc
375 West Street
West Bridgewater, MA 02379
BK990032 1/20/2000
MCS+ LN8150 Automated blood cell separator that automatically removes whole blood from a donor, separates the blood into components (RBC, white cells, plasma, and platelets), retains one or more of the components and returns the remainder to the donor Haemonetics Corp
400 Wood Road
Braintree, MA 02184
BK990033 1/20/2000
Magic Client Server Ver. 5.1 Blood Establishment Computer Software Indico, Inc
MEDITECH Circle
Westwood, MA 02090
BK980046 2/8/2000
RadTag Label for blood bags to indicate that the product has been processed at the levels of irradiation currently used in the processing of blood MEDITECH Medical Information Technology, Inc
6325 103rd Street
Suite 137
Edmonton, Alberta
T6G 2E1 CANADA
BK000008 3/1/2000
Fenwal Amicus Separator Collection of 3 Platelet Products Automated Blood Cell Separators Baxter Healthcare Corp
Route 120 & Wilson Road
Round Lake, IL 60073
BK990009 3/3/2000
COBE Trima with the r/LS RBC Leukoreduction Filter Automated Blood Cell Separators COBE BCT
120 Oak Street
Lakewood, CO 80215
BK990040 3/3/2000
Ortho Lab with Ortho Lab IC (Instrument Concentrator) Blood Establishment Computer Software Ortho-Clinical Diagnostics, Inc
1001 U.S. Highway 202
P.O. Box 350
Raritan, NJ 08869-0606
BK990030 4/3/2000
Information Data Management Surround System 2.0 Blood Establishment Computer Software Information Data Management, Inc
9701 West Higgins Road
Rosemont, IL 60018
BK000016 4/7/2000
COBE Trima Intended for the collection, pre-storage leukoreduction, and storage of platelet products COBE BCT
1201 Oak Street
Lakewood, CO 80215
BK990025 4/7/2000
Total Containment Device Modification to provide for a different clamp or Taper Lock to accomodate up to nominally sized 4.3mm OD tubing DENCO, Inc
P.O. Box 9600
Wilmington, DE 19809
BK000022 4/18/2000
Digi-Trax Donor-ID 2.0 Blood Establishment Computer Software Digi-Trax Corp
1550 Barclay Boulevard
Buffalo Grove, IL 60089
BK000020 4/20/2000
Capture-S Solid Phase Assay Donor testing to detect antilipid antibodies in donor blood samples Immucor, Inc
3130 Gateway Drive
Norcross, GA 30091-5625
BK000021 6/22/2000
P2K Plasma Center Module 2000 Ver.1.0 Blood Establishment Computer Software Fifth Dimension Information Systems
Suite 500
Merill Lynch Tower
Edmonton Centre
Edmonton, Alberta T5J 2Z2
CANADA
BK000026 06/22/2000
Modified Plasma Bag Y-sampling device used to permit removal of samples from plasma bags after the collection procedure is complete MEDSEP Corp
330 Turnbull Canyon Road
City of Industry, CA 91745
BK000032 09/27/2000
B-Screen Solid Phase ELISA Assay Test system for detection of IgG antibodies to HLA Class II Antibodies Genetic Testing Institute
150 N. Patrick Blvd
Brookfield, WI 53045
BK990043 10/02/2000
Quick ID Solid Phase ELISA HLA Typing Kit to detect panel reactive HLA Class I IgG antibodies (PLA) Genetic Testing Institute
150 N. Patrick Blvd
Brookfield, WI 53045
BK000015 10/17/2000
Haemonetics LN832F Two-unit red cell disposable set with leukocyte reduction filter to collect leukocyte reduced by gravity filtration, and store 2 units of apheresis red blood cells for up to 42 days Haemonetics Corp
400 Wood Road
Braintree, MA 02184
BK990044 10/27/2000
R & D Leuko-Reduced RBC Control Automated Differential White Blood Cell Counter R & D Systems, Inc
614 McKinley Place NE
Minneapolis, MN 55413
BK000035 12/13/2000
R & D Leuko-Reduced Plt Control Automated Differential White Blood Cell Counter R & D Systems, Inc
614 McKinley Place NE
Minneapolis, MN 55413
BK000036 12/13/2000
Viroclear Quality control kits for bloodborne pathogen testing of donors Blackhawk BioSystems, Inc
12945 Alcosta Blvd
San Ramon, CA 94583
BK000041 12/28/2000