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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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2003 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 Number Applicant Approval Date
Pel Freez HLA High Resolution SSP UniTray PCR based HLA typing evaluation method designed to provide resolution of the HLA Class I (A, B, C) and Class II (DRB) Loci using genomic DNA BK020068 Pel-Freez Clinical Systems, LLC
9099 N. Deerbrook Trail
Brown Deer, WI 53223
1/14/2003
ALYX Component Collection System Automated system for centrifugal blood separation - filtration BK020059 Baxter Healthcare Corp - Fenwal Division
Route 120 & Wilson Road
Round Lake, IL 60073-0490
1/23/2003
Capture-R Ready Indicator Red Cells Anti-IgG coated red blood cells for use in the Capture-R solid phase assays for the detection of unexpected IgG antibodies specific for antigen found on human erythrocytes. Capture-R Ready Indicator Red Cells are used in manual and semi-automated methods with Capture-R assays in the ABS2000 automated blood bank instrument BK020053 Immucor, Inc
3130 Gateway Drive
Norcross, GA 30091-5625
1/27/2003
Capture-R Control Cells IgG-coated red cells intended to be used only with the ABS2000 blood bank analyzer to determine if the anti-IgG coated Capture-R Ready Indicator Red Cells have become neutralized BK020054 Immucor, Inc
3130 Gateway Drive
Norcross, GA 30091-5625
1/27/2003
ViroSeq HIV-1 Genotyping System with the 3100 Genetic Analyzer Detecting HIV genomic mutations that confer resistance to specific types of antiretroviral drugs, such as an aid in monitoring and treating HIV infection BK030005 Applied Biosystems / Celera Diagnostics
1401 Harbor Bay Parkway
Alameda, CA 94502
1/29/2003
ASI Treponema Pallidum Hemagglutination Assay (TPHA) Test Qualitative microhemagglutination test for the presence of IgG and IgM antibodies to Treponema pallidum (causative agent for syphilis) in serum and EDTA plasma BK020031 Arlington Scientific, Inc
1840 N. Technology Drive
Springville, UT 84663
1/30/2003
LOGIC 1.0 Blood Establishment Computer Software BK020058 Fifth Dimension Information Systems
Suite 500
Merril Lynch Tower
Edmonton Centre
Edmonton, Alberta, T5J 2Z2
CANADA
2/3/2003
LeukoSure Enumeration Kit with Leuko-Trol RBC Control Cells and Leuko Trol Platelet Control Cells Quality control kits for Blood Banking Reagents; to prepare and enumerate WBC in leukoreduced red blood cells and platelet products by flow cytometry BK020063 Beckman Coulter, Inc
11800 SW 147 Avenue
(M/C: 31-B06)
Miami, FL 33196-2500
2/3/2003
LABTYPE SSO Typing Test Qualitative test for HLA, non-diagnostic DNA typing of Class I or Class II alleles BK020055 One Lambda, Inc
21001 Kittridge St
Conoga Park, CA 91303
2/4/2003
Hemocare LifeLine Version, 1.0 Blood Establishment Computer Software BK020046 Mediware Information Systems, Inc
900 Oakmont Lane
Westmont, IL, 60659
2/14/2003
Olympus PK TP System Test for Syphilis and Treponema (for donor testing); to remove the PK7100 analyzer from the labeling & implement an extension of the sample age limitations for testing plasma for antibodies to Treponema pallidum BK030007 Fujirebio Diagnostics, Inc
201 Great Valley Parkway
Malvern, PA 19355
2/21/2003
UniMatch Plus Qualitative test for HLA, non-diagnostic; supports evaluation of HLA typing results BK030003 Pel-Freez Clinical Systems, LLC
9099 N. Deerbrook Trail
Brown Deer, WI, 53223
2/25/2003
Greiner Vacuette EDTA K3 Tube Blood specimen collection device (vacuum); for additional claim for use in immunohematology testing BK030001 Greiner Bio-One GmbH
Greiner Vacuette North America, Inc
4238 Capital Drive
Monroe, NC, 28112
2/26/2003
SoftDonnor 4.1 Blood Establishment Computer Software BK020006 Soft Computer Consultants, Inc
34350 U.S. HWY 19 N
Palm Harbor, FL 34684
2/27/2003
Transwaag Disk 01 Blood mixing and weighing device to continuously weigh and mix blood with anticoagulation solution in the blood donation bag during the mobile or stationary collection process BK030006 Sarstedt, Inc
P.O. Box 468
Newton, NC 28658-0468
2/27/2003
Olympus PK7200 Automated Microplate System Automated analyzer intended exclusively for agglutination technology using Olympus terraced microplates; can be used to perform donor ABO/Ph grouping, including weak D testing, as well as, syphilis and CMV qualitative screening BK030009 Olympus America, Inc
Diagnostic Systems Division
3131 West Royal Lane
Irving, TX 75063
3/3/2003
TRUGENE HIV-1 Genotyping Kit and OpenGene DNA Sequencing System Used to update software version for additional rules and data BK030015 Visible Genetics, Inc
700 Bay Street
Suite 1000
Toronto, Ontario
M5G 1Z6 Canada
3/14/2003
NGTL Automation System (NAS) 5.2.0 Blood Establishment Computer Software BK020032 American Red Cross Blood Services
Quality and Regulatory Affairs
Arlington, VA 22209
3/20/2003
MedMira Rapid HIV Test For detection of HIV-1 and HIV-2 Antibodies BP000023 MedMira Labs
155 Chain Lake Drive
Bayers Lake
Halifax, CANADA B35 1B3
4/16/2003
SoftBank II 23 Blood Establishment Computer Software BK030018 Soft Computer Consultants Inc
34350 U.S. HWY 19 N
Palm Harbor, FL 34684
4/17/2003
Donor Hemoglobin Checker System For use in conjunction with blood donor screening programs for the quantitative determination of hemoglobin in capillary, venous or arterial blood samples BK030020 HemoCue, Inc
9229 Cranford Drive
Potomac, MD 20854
4/17/2003
COBE Spectra Apheresis System/Blood component disposable collection sets for apheresis To remove mononuclear cells (MNC) or granulocytes [polymorphonuclear cells (PMN)] from a patient BK020041 Gambro BCT, Inc
10811 W. Collins Ave
Lakewood, CO 80215-4498
4/23/2003
Vista Information System 2.1 Blood Establishment Computer Software BK030021 Gambro BCT, Inc
10811 W. Collins Ave
Lakewood, CO 80215-4498
5/1/2003
Leucolab LCG2 Leukoreduction System for Red Blood Cells Leukoreduction of a single unit of red cells, at room temperature (20 to 24 °C) within 8 hours of collection, or at 1 to 6 °C up to 3 days after collection BK030008 Maco Pharma
c/o Hoppe Regulatory Consultants
2335 Massey Lane
Decatur, GA 30033
5/2/2003
Ortho ProVue, Software Version: 2.10 Blood Establishment Computer Software BK030023 Micro Typing Systems, Inc
1295 S.W. 29th Ave
Pompano Beach, FL 33069
5/14/2003
Imugard III-PL Leukocyte reduction filter Leukocyte reduction filter for preparation of leukocyte-reduced platelets up to 3 days after collection BK020033 Terumo Medical Corp
125 Blue Ball Road
Elkton, MD 21921
5/22/2003
Procleix NAT Tracker Blood Establishment Computer Software BK030030 Rubin and Poor, Inc
155 Maplewood Ave #5
Maplewood, NJ 07040
5/23/2003
Vironostika HIV-1 Plus O Microelisa System Indicated for the qualitative detection of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1), including Group O, in human specimens collected as serum, plasma, or dried blood spots BP020066 bioMerieux, Inc
100 Rodolphe Street
Durham, NC 27712
6/6/2003
ThermoGenesis Thawer For thawing frozen plasma and frozen glycerolized red blood cells BK030011 Thermogenesis
3146 Gold Camp Drive
Suite 206
Rancho Cordova, CA 95670-6022
6/10/2003
ViroSeq HIV-1 Genotyping System with the 3700 Genetic Analyzer Intended for use in detecting HIV genomic mutations that confer resistance to specific types of antiretroviral drugs, such as an aid in monitoring and treating HIV infection BK030033 Celera Diagnostics
1401 Harbor Bay Parkway
Alameda, CA 94502
6/11/2003
Level 1 Fluid warming System Non-electromagnetic Blood/Fluid warmer to provide rapid flow of warmed fluids BK020043 Level 1 Technologies, Inc
160 Weymouth Street
Rockland, MA 02370
6/16/2003
BD IMAGN Microvolume Fluorimeter and BD IMAGN rWBC Assay Kit Device and assay kit that detects residual white blood cells in leukoreduced blood cell products BK030027 BD Biosciences
2350 Qume Drive
San Jose, CA 95131-1807
7/10/2003
Fresenius Compomat G4 & Compomaster NT Used for blood component separation and preparation BK030022 Fresenius Hemocare Inc
6675 185th Avenue NE
Suite 100
Redmond, WA 98052
7/11/2003
Greiner Vacuette EDTA K2 Evacuated Blood Collection Tube Evacuated blood collection tube; addition of claim for use in immunohematology testing BK030032 Greiner Bio-One GmbH
4238 Capital Drive
Monroe, NC 28112
7/18/2003
BacT/ALERT BPN Culture Bottle Used the the BacT/ALERT Microbial Detection System for quality control testing of leukocyte reduced apheresis platelet (LRAP) units; supports anaerobic growth BK030034 BioMerieux, Inc
100 Rodolphe Street
Durham, NC 27712
7/18/2003
imExpress 7.2.5 Blood Establishment Computer Software BK020057 Data Innovations, Inc
120 Kimball Ave, Suite 100
South Burlington, VT 05403
7/29/2003
BacT/ALERT BPA Culture Bottle Used with the BacT/ALERT Microbial Detection System for quality control testing of leukocyte reduced apheresis platelet (LRAP) units. Supports aerobic growth BK030035 BioMerieux, Inc
100 Rodolphe Street
Durham, NC 27712
8/6/2003
Cerner Millennium PathNet Blood Bank Donor (PA-22200) 2003.01 Blood Establishment Computer Software BK030028 Cerner Corp
2800 Rock Creek Parkway
Kansas City, MO 64117-2551
8/19/2003
Magellan Autologous Platelet Separation System To be used in the clinical laboratory or intraoperatively at the point of care for the safe & rapid preparation of platelet poor plasma & platelet concentrate (platelet rich plasma) from a small sample of blood BK030040 Medtronic Sofamor Danek
1800 Pyramid Place
Memphis, TN 38132
9/3/2003
Haemonetics Model 215 Automated Glycerolyzation/Deglycerolyzation and Cell Washing System To glycerolize and deglycerolize red blood cells derived from whole blood that have been stored in any approved anticoagulant/additive solution for 6 days at 1-6 °C BK030031 Haemonetics Corp
400 Wood Road
Braintree, MA 02184
9/10/2003
Platelet collection sets for the COBE Spectra Apheresis System and the Trima Automated Blood Component Collection System 7 day Platelet Storage Using Platelets Collected with COBE Spectra Apheresis Systems and the Trima Automated Blood Component Collection Systems BK010037 Gambro BCT, Inc
10811 W. Collins Ave
Lakewood, CO 80215-4498
9/24/2003
OriGen Cryostore Freezing Bags Intended to be used for blood component freezing BK030036 OriGen BioMedical
9709 Beck Circle
Austin, TX 78758
10/1/2003
TRUGENE HIV-1 Genotyping Kit and OpenGene DNA Sequencing System To market product with a revised OpenGene software incorporating the interpretation algorithm for the GuideLines Rules 8.0 BK030052 Bayer HealthCare
Diagnostics Division
700 Bay Street Suite 1000
Toronto, Canada
10/8/2003
Donor-ID Blood Establishment Computer Software BK030049 Healthcare-ID
1635 Barclay Blvd
Buffalo Grove, IL 60089
10/31/2003
Haemonetics Model 215 Automated Glycerolization/deglycerolization System To glycerolize & deglycerolize red blood cells derived from whole blood that have been stored in any approved anticoagulant/additive solution for 6 days at 1-6°C prior to glycerolization BK030062 Haemonetics Corp
400 Wood Road
Braintree, MA 02184
12/10/2003
HemoCue Donor Hb Checker Control Intended for use in the verification of the precision and accuracy of the HemoCue Donor Hb Checker System BK030067 HemoCue, Inc
9229 Cranford Drive
Potomac, MD 20854
12/19/2003
WebLab Online Laboratory System 2.0 Blood Establishment Computer Software BK030065 Mississippi Blood Services, Inc
1995 Lakeland Drive
Jackson, MS 39216
12/22/2003
Uni-Gold Recombigen HIV-1 Detection of antibodies to HIV-1 in human serum, plasma or whole blood (venipuncture) specimens BP030025 Trinity Biotech Plc
IDA Business Park
Southern Cross Road
EL, Ireland
Bray, County Wicklow
12/23/2003
Aldecount Progenitor Cell Enumeration Kit To identify and enumerate by flow cytometry low side scatter cells that express high levels of aldehyde dehydrogenase (ALDHbrSSClo) in human peripheral blood and leukapheresis samples BK030064 Stemco Biomedical, Inc
2810 Meridian Parkway
Suite 148
Durham, NC 27713
12/31/2003
LABScreen Products for use with LACScan 100 flow analyzer Uses microbeads coated with HLA Class I or Class II Antogens to detect Class I/Class II HLA antibodies BK030069 One Lambda Inc
21001 Kittridge St
Canoga Park, CA 91303
12/31/2003