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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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2002 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
Atago SP-D2 Donor screening at blood donation centers, to determine the total protein concentration in serum or plasma BK010043 VEEGEE Scientific
13600 NE 126th Place Suite A
Kirkland, WA 98034
1/2/2002
Chiron Procleix NAT Tracker 1.0E Blood Establishment Computer Software BK010025 Rubin & Poor, Inc
155 Maplewood Ave
Suite 5
Maplewood, NJ 07045
1/3/2002
Hemoflow Model 400 with Data Scanner For use in blood banks and similar settings to assist in collecting blood donations BK010031 Applied Science
964-B Golden Gate Terrace
Grace Valley, CA 95945
1/23/2002
Plasmapheresis Data System III 1.0 Blood Establishment Computer Software BK010032 Medserv, Inc
71 South Bedford Road
Mount Kisco, NY 10549
2/5/2002
The Chiron Procleix System Blood Establishment Computer Software BK000051 Gen-Probe
10210 Genetic Center Drive
San Diego, CA 92121-4362
2/8/2002
BacT/ALERT Culture Bottles Bacterial detection systems for the recovery and detection of aerobic and anaerobic microorganisms (bacteria and fungi) from blood, and other normally sterile body fluids and platelets BK000042 BioMerieux, Inc
100 Akzo Avenue
Durham, NC 27712
2/15/2002
Chiron Procleix HIV-1/HCV Controls HIV-1/HCV external quality control kits used for bloodborne pathogen testing of donors BK010003 Gen-Probe
10210 Genetic Center Drive
San Diego, CA 92121-4362
2/22/2002
Trima Automated Blood Component Collection System Automated blood cell separators used for collection, pre-storage leukocyte reduction, and storage of platelet, plasma, and red blood cell products BK010006 Gambro BCT, Inc
10811 Collins Ave
Lakewood, CO 80215-4498
2/27/2002
Plasma Pooling Bottle II Empty container for the collection and storage of donor plasma for further manufacture by automated plasmapheresis BK020001 Haemonetics Corp
400 Wood Road
Braintree, MA 02184
3/29/2002
Trugene HIV-1 Genotyping Kit & Open Gene DNA Sequencing System HIV test kit used in the detection of genomic mutations BK020005 Visible Genetics, Inc
700 Bay Street, Suite 1000
Toronto, CANADA
4/24/2002
Donor-ID 2.2 Blood Establishment Computer Software BK010049 Digi-Trax Corp
1550 Barclay Boulevard
Buffalo Grove, IL 60089
4/26/2002
stemONE System for EPICS XL/XL-MCL Flow Cytometry Systems In Vitro Diagnostic use for the simultaneous identification and enumeration of CD45+ and dual-positive CD34 (CD45+/CD34+) cell population percentages and absolute counts BK010044 Beckman Coulter, Inc
11800 SW 147 Avenue
(M/C: 31-B06)
Miami, FL 33196-2500
5/20/2002
LifeTrak Lab 2.03 For management of data related component production, testing, and labeling of donation blood and testing of external samples BK010052 Mediware Information Systems, Inc
9000 Harry Hines Blvd
Dallas, TX 75235
6/17/2002
Olympus PK7200 Automated Microplate System Fully automated analyzer used to perform donor ABO/Rh grouping, including weak D testing, syphilis and CMV qualitative screening BK020024 Olympus America Inc
Diagnostic System Division
3131 West Royal Lane
Irving, TX 75063-3104
7/08/2002
The GAMBRO BCT Vista Information System, Independent Solution Blood Establishment Computer Software BK020015 Gambro BCT, Inc
10811 W. Collins Ave
Lakewood, CO 80215-4498
7/15/2002
Abbott Prism Retest Server 1.0 Blood Establishment Computer Software BK010036 Abbott Laboratories
100 Abbott Park Road
Abbott Park, IL 60064-3500
7/17/2002
Amicus Separator, Mononuclear Cell Collection Automated blood cell separator used for the collection of mononuclear cells BK000047 Baxter Healthcare Corp
Route 120 and Wilson Road
Round Lake, IL 60073
7/31/2002
Serology SQL LIMS 1.0 Blood Establishment Computer Software BK020002 Baxter Healthcare Corp
550 North Brand Blvd
Glendale, CA 91203
8/07/2002
Biotest HLA SSP Kit Qualitative test for HLA Class I or Class II alleles BK020004 Biotest Diagnostics Corp
66 Ford Road, Suite 131
Denville, NJ 07834
8/07/2002
Amicus Separator, Concurrent Collection of Red Blood Cells Automated Blood Cell Separator for the simultaneous collection of platelets, plasma, and red blood cells BK000039 Baxter Healthcare Corp
Route 120 and Wilson Road
Round Lake, IL 60073 US
8/26/2002
Cygnet System Automated Blood Cell Separator to separate whole blood into its components (concurrent collection of 2 units of Red Blood Cells) BK010033 Baxter Healthcare Corp
Route 120 and Wilson Road
Round Lake, IL 60073 US
8/27/2002
SoftBank II 22 Blood Establishment Computer Software BK020021 Soft Computer Consultants, Inc
34350 U.S. HWY 19 N
Palm Harbor, FL 34684
9/11/2002
VERSANT HIV-1 RNA 3.0 Assay (bDNA) HIV detection test for the direct quantitation of HIV-1 RNA in plasma of HIV-1 infected individuals BP000028 Bayer Corp
P.O. Box 2466
Berkeley, CA 94702
9/11/2002
Trima Automated Blood Collection System (Single Stage) Automated blood cell separator-filtration BK010046 Gambro BCT, Inc
10811 W. Collins Ave
Lakewood, CO 80215-4498
9/18/2002
Trima Automated Blood Collection System Automated blood cell separator-filtration BK010050 Gambro BCT, Inc
10811 W. Collins Ave
Lakewood, CO 80215-4498
9/18/2002
UltraCW (with Software version 3.13) Blood Establishment Computer Software BK020029 Helmer Labs, Inc
15425 Herriman Boulevard
Noblesville, IN 46060
10/4/2002
IDM Surround Sound System, Version 3.2 Blood Establishment Computer Software BK020038 Information Data Management Systems, Inc
9701 West Higgins Road
Rosemont, IL 60018
10/8/2002
BacT/ALERT SN Culture Bottles Bacterial detection systems for the recovery and detection of aerobic and anaerobic microorganisms (bacteria and fungi) from blood, and other normally sterile body fluids and platelets BK020022 BioMerieux, Inc
100 Rodolphe Street
Durham, NC 27712
10/10/2002
BacT/ALERT SA Culture Bottles Bacterial detection systems for the recovery and detection of aerobic and anaerobic microorganisms (bacteria and fungi) from blood, and other normally sterile body fluids and platelets BK020023 BioMerieux, Inc
100 Rodolphe Street
Durham, NC 27712
10/10/2002
Pall Bacterial Detection System (BDS) For use with the Pall BDS Oxygen Analyzer in Qualitative procedures for the recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria) for quality control testing of leukocyte reduced apheresis or whole blood derived platelet units BK020014 Medsep Corp
1630 Industrial Park Street
Covina, CA 91722
10/22/2002
System for Plasma Identification (SPI) 1.0 Blood Establishment Computer Software BK020020 ZLB Bioplasma AG
Wannkdorfstrasse 10
Postfach 3000
Bern, SZ
10/30/2002
OraSure OraQuick Rapid HIV-1 Antibody Test Detection of HIV-1 antibodies in fingerstick whole blood specimens BP010047 OraSure Technologies, Inc
150 Webster St
Bethlehem, PA 18015-1389
11/7/2002
Trugene HIV-1 Genotyping Kit and OpenGene DNA Sequencing System Detection of HIV genomic mutations as an aid in monitoring and treating HIV infection Software revision included GuideLines Rules 6.0 BK020042 Visible Genetics, Inc
700 Bay St, Suite 1000
Toronto, CANADA
11/7/2002
Chiron Procleix System Blood Establishment Computer Software BK020045 Gen-Probe
10210 Genetic Center Dr
San Diego, CA 92121-42362
11/21/2002
COBAS AmpliScreen System For use in clinical laboratories for the automation of Polymerase Chain Reaction test procedures BK020018 Roche Molecular Systems, Inc
4300 Hacienda Dr
PO Box 9002
Pleasanton, CA 94566-0990
11/26/2002
ViroSeq HIV-1 Genotyping System For use in detecting HIV genomic mutations that confer resistance to specific types of antiretroviral drugs, as an aid in monitoring and treating HIV infection BK010024 Celera Diagnostics/Applied Biosystems, Inc
1401 Harbor Bay Parkway
Alameda, CA 94502
12/10/2002
COBAS AmpliScreen Data Output Management System (DOMS) 1.00.04 Blood Establishment Computer Software BK020025 Roche Molecular Systems, Inc
4300 Hacienda Drive
PO Box 9002
Pleasanton, CA 94566-0990
12/10/2002
LeukoConnect
Pre-Storage Sterile Connect Leukoreduction Set with Sepacell Filter for Red Blood Cells
For leukoreduction of one unit of Red Blood cells in additive solution at ambient temperature within 8 hours after blood collection, or at refrigerated temperature within 72 hours after blood collection BK020008 Baxter Healthcare Corp - Fenwal Division
Route 120 & Wilson Road
Round Lake, IL 60073-0490
12/16/2002
NucliSens HIV-1 QT RNA External Controls Reagents with assigned values intended to be used with the NucliSens HIV-1 QT assay for quantitation of HIV-1 RNA in human plasma BK020060 BioMerieux, Inc
100 Rodolphe St
Durham, NC 27712
12/18/2002
MCS+ Mobile Collection System Automated blood cell separator-filtration used in conjunction with the Single Donor Platelets Protocol and single use sterile disposable sets BK010035 Haemonetics Corp
400 Wood Rd
Braintree, MA 02184
12/20/2002
Cascade Medical Fibrinet, Autologous Platelet System For the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small sample of blood at the patient point of care BK020051 Cascade Medical Enterprises, LLC
20 Greenup Court
Wayne, NJ 07470
12/20/2002
ALYX System For use in blood collection establishments to collect and separate whole blood into its components BK020056 Baxter Healthcare Corp
Route 120 & Wilson Road
Round Lake, IL 60073
12/20/2002