• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

  • Print
  • Share
  • E-mail

2004 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
Haemonetics LN994CF·CPP·BA Extended Storage Platelet and Plasma Apheresis Set To be used to obtain a sample of the platelets collected that is greater or equal to 4 mL BK030084 Haemonetics Corp
400 Wood Road
Braintree, MA 02184
1/9/2004
Configurable Manual Batch Entry 1.1A Blood Establishment Computer Software BK030073 Rubin & Poor, Inc
155 Maplewood Avenue #5
Maplewood, NJ 07040
1/14/2004
Trima Accel Device modification for the Trima Automated Blood Collection System (Single Stage System) to change the operating system from QNX to VxWorks BK030083 Gambro BCT, Inc
10811 W. Collins Ave
Lakewood, CO 80215-4498
1/14/2004
ViroSeq HIV-1 Genotyping System v2.0 To detect drug resistance mutations in the protease and reverse transcriptase regions of subtype B HIV-1 with a viral load ranging from 2,000 to 750,000 RNA BK030088 Celera Diagnostics, LLC
1401 Harbor Bay Parkway
Alameda, CA 94502
1/22/2004
Dynal Reli SSO HLA-A Typing Kit Provides a low to medium resolution HLA-A typing result BK030056 Dynal Biotech Ltd
Bromborough, Wirral
United Kingdom
1/29/2004
Dynal Reli SSO HLA-B Typing Kit Provides a low to medium resolution HLA-B typing result BK030057 Dynal Biotech Ltd
Bromborough, Wirral
United Kingdom
1/29/2004
Dynal Reli SSO HLA-Cw Typing Kit Provides a low to medium resolution HLA-Cw typing result BK030058 Dynal Biotech Ltd
Bromborough, Wirral
United Kingdom
1/29/2004
Dynal Reli SSO HLA-DQB1 Typing Kit Provides a low to medium resolution HLA-DQB1 typing result BK030059 Dynal Biotech Ltd
Bromborough, Wirral
United Kingdom
1/29/2004
Dynal Reli SSO HLA-DRB Typing System Provides a low to medium resolution HLA-DRB1 & DRB3/4/5 typing result BK030060 Dynal Biotech Ltd
Bromborough, Wirral
United Kingdom
1/29/2004
Pall eBDS Intended 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 and whole blood derived platelet units BK030082 Medsep Corp
1630 Industrial Park Street
Covina, CA 91722
2/4/2004
Olympus PK7200 Automated Microplate System A fully automated analyzer using agglutination technology to perform donor ABO/Rh grouping, including weak D testing BK040003 Olympus America Inc
Diagnostic Systems Division
3131 West Royal Lane
Irving, TX 75063-3104
2/6/2004
ITL SampLok Sampling Kit To transfer samples from blood bags or other containers with sterile docking compatible tubing to vacuum containers for laboratory tests BK030087 ITL Corp Pty, Ltd
41-45 Tennant Street
Canberra ACT 2609
Australia
2/18/2004
Haemonetics 4mL Sampling System Intended to be sterile connected to a platelet storage container for the purpose of obtaining a 4 milliliter sample of platelets BK040001 Haemonetics Corp
400 Wood Road
Braintree, MA 02184
2/27/2004
R&D Donor Checker Hematology Control Designed to monitor values obtained from the HemoCue Donor Hb Checker System BK040012 R & D Systems, Inc
614 McKinley Place NE
Minneapolis, MN 55413
3/5/2004
BacT/ALERT BPN Culture Bottles Used with the BacT/ALERT Microbial Detection System for quality control testing of leukocyte reduced apheresis platelets (LRAP) units, and leukocyte reduced single units whole blood platelet concentrates (WBPC). BacT/ALERT BPN culture bottles support the growth of anaerobic and facultative anaerobic microorganisms (bacteria) BK030075 BioMerieux, Inc
100 Rodolphe Street
Durham, NC 27712
3/8/2004
BacT/ALERT BPA Culture Bottles Used with the BacT/ALERT Microbial Detection System for quality control testing of leukocyte reduced apheresis platelets (LRAP) units, and leukocyte reduced single units of whole blood platelet concentrates (WBPC). BacT/ALERT BPA culture bottles support the growth of aerobic microorganisms (bacteria and fungi) BK030076 BioMerieux, Inc
100 Rodolphe Street
Durham, NC 27712
3/8/2004
ALYX Component Collection System and Amicus Separator System A study of the effects of freezing or irradiation BK030085 Baxter Healthcare Corp - Fenwal Division
Route 120 & Wilson Road
Round Lake, IL 60073
3/15/2004
Fresenius Compoguard & Donationmaster NT Is used in blood banks for blood collection and data registration BK040005 Fresenius Hemocare Inc
95 Hayden Avenue
Lexington, MA 02420
3/26/2004
Haemonetics LN994CF-BA Extended Storage Platelet and Plasma Apheresis Set with Leukocyte Reduction Filter, and 4 mL Sampling System To be used to collect 1 unit of platelets, leukoreduced (with or without plasma). May be used to collect 2 units of platelets. The attached 4 mL sampling system used to obtain a sample of the platelets collected that is greater or equal to 4 mL BK040020 Haemonetics Corp
400 Wood Road
Braintree, MA 02184
3/29/2004
HCLL 2.6 Blood Establishment Computer Software BK030078 Mediware Information Systems, Inc
4545 Fuller Drive, Ste 320
Irving, TX 75038
4/8/2004
Galileo QC Cell Used as a negative and positive control in assays performed on the Galileo automated blood bank analyzer BK040014 Immucor, Inc
3130 Gateway Drive
Norcross, GA 30091-5625
4/22/2004
Monoclonal Control Control for low protein Blood Grouping Reagents manufactured by Immucor and Gamma in Slide, Tube and Microplate Tests BK040010 Immucor, Inc
3130 Gateway Drive
Norcross, GA 30091-5625
4/23/2004
Galileo version 1.3.6 SP4/DMS version 1.26 A microprocessor-controlled instrument to automate test processing, result interpretation, data management functions and immunohematology assays using a microplate based platform BK040013 Immucor, Inc
3130 Gateway Drive
Norcross, GA 30091-5625
4/23/2004
DAT Positive Control Cell Intended to be used as a positive control in direct antiglobulin tests performed on the Galileo blood bank analyzer BK040023 Immucor, Inc
3130 Gateway Drive
Norcross, GA 30091-5625
4/23/2004
Capture-R Select Solid Phase System Provides modified microwells for the immobilization of human erythocytes for use in solid phase assays for the detection of IgG red cell antibodies to corresponding red cell antigens BK040024 Immucor, Inc
3130 Gateway Drive
Norcross, GA 30091-5625
4/28/2004
BD Vacutainer Plus Plastic Serum Tubes with Clot Activator To be used for immunohematology testing including but not limited to ABO grouping, Rh typing, antibody screening, red cell phenotyping and DAT testing, which requires red blood cells or serum BK040030 Becton, Dickinson & Company
1 Becton Drive, MC 300
Franklin Lakes, NJ 07417-1885
5/5/2004
Stem-Kit Reagents For In Vitro Diagnostic Use for the simultaneous identification and enumeration of CD45+ and dual-positive CD45+ CD34+ cell population percentages and absolute counts in biological specimens by flow cytometry BK040032 Beckman Coulter, Inc
11800 SW 147 Avenue
(M/C: 31-B06)
Miami, FL 33196-2500
5/5/2004
SoftBank II version 23 with SoftScape Blood Establishment Computer Software BK040028 Soft Computer Consultants Inc
34350 U.S. HWY 19 N.
Palm Harbor, FL 34684
5/7/2004
PCS2 Plasma Collection System Automated cell separator and blood component collector BK040025 Haemonetics Corp
400 Wood Road
Braintree, MA 02184
6/2/2004
LD-2000 Leukocyte Counter Intended to be used to enumerate residual leukocytes in leukocyte reduced blood products for quality control testing BK030037 Kowa Company, Ltd
c/o Quintiles Consulting
1801 Rockville Pike, Suite 300
Rockville, MD 20852
6/14/2004
GPS II Platelet Concentrate Separation Kit Designed to be used for the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small sample of blood at the patient's point of care. The PRP can be mixed with autograft and allograft bone prior to application to an orthopedic surgical site as deemed necessary by the clinical use requirements BK040036 Biomet,Inc
P.O.Box 587
56 East Bell Drive
Warsaw, IN 46582
6/18/2004
Osteokin System Preparation of platelet rich plasma BK040017 Orthogen Therapeutics, GmbH
Graf-Adolf-Str. 43
D-40210 Dusseldorf
Germany
6/23/2004
Antibody Monitoring System Class I and Class II (AMS1 and AMS1+2) Solid Phase Enzyme linked Immunoassay for the detection of IgG Antibodies to donor-specific HLA Class I and Class II Antigens BK040019 GTI, Inc
20925 Crossroads Circle
Waukesha, WI 53186
7/6/2004
Haemonetics MCS+8150 Apheresis System To allow filtration of red cells at up to 72 hours post-collection for red cells collected with the 2 RBC-F protocol on the MCS+ 8150 BK040041 Haemonetics Corp
400 Wood Road
Braintree, MA 02184
7/12/2004
Lifecodes LifeScreen: A Luminex 100 Screening Assay for the Detection of IgG Antibodies to HLA Class I and Class II Molecules of Human Origin A qualitative test that can be used to detect the presence of IgG antibodies sensitized to HLA by transfusion, pregnancy or tissue transplantation BK040034 GTI, Inc
20925 Crossroads Circle
Waukesha, WI 53186
7/16/2004

Lifecodes ID Class I: A Luminex 100 screening assay for the qualitative detection of IgG panel reactive antibodies (PRA) to HLA Class I molecules

Lifecodes ID Class II: A Luminex 100 screening assay for the qualitative detection of IgG panel reactive antibodies (PRA) to HLA Class II molecules

Qualitative tests that can be used to detect the presence of IgG panel reactive antibodies produced in patients sensitized to HLA Class I or Class II molecules by transfusion, pregnancy, or tissue transplantation BK040035 GTI, Inc
20925 Crossroads Circle
Waukesha, WI 53186
7/16/2004
Instrument Interface Engine, Version 1.0 Blood Establishment Computer Software BK040047 Mediware Information Systems, Inc
4545 Fuller Drive, Ste 320
Irving, TX 75038
7/16/2004
Vacuette EDTA K2 tube; Vacuette EDTA K3 tube For use in Viral Marker Testing of blood donors BK040018 Sienna Partners
P.O. Box 103
Baldwin, MD 21013
7/28/2004
Chiron CPT Pooling Software, Version 2.0.0.2 Blood Establishment Computer Software BK040058 Chiron Corp
4560 Horton Street
Emeryville, CA 94608-2916
7/28/2004
LabType Visual For the evaluation of One Lambda HLA DNA typing test results BK040049 One Lambda, Inc
21001 Kittridge St.
Canoga Park, CA 91303
8/9/2004
SoftBank II v23.1 with Database Management System Interface (DMSI) Blood Establishment Computer Software BK040048 Soft Computer Consultants, Inc
34350 U.S. HWY 19 N.
Palm Harbor, FL 34684
8/23/2004
Greiner VACUETTE No Additive Evacuated Blood Collection Tubes and Serum Clot Activator Blood Collection Tubes Used for viral marker testing in screening and clinical laboratories BK040066 Sienna Partners
P.O. Box 103
Baldwin, MD 21013
9/10/2004
stemCXP System for the FC 500 with CXP Software Intended for In Vitro Diagnostic Use to simultaneously identify and enumerate CD45+ and CD45+/CD34+ dual positive cell populations BK040055 Beckman Coulter, Inc
11800 SW 147 Avenue
(M/C: 31-B06)
Miami, FL 33196-2500
9/16/2004
R & D Plasma Hemoglobin Hematology Control To monitor values obtained from the HemoCue Plasma/Low Hemoglobin Photometer BK040063 R & D Systems, Inc
614 McKinley Place NE
Minneapolis, MN 55413
9/17/2004
Scansystem Bacterial Detection Device To detect bacterial contamination in leukocyte reduced apheresis platelets (LRAP) for quality control testing BK040031 Hemosystem, SA
1899-A Billingsgate Circle
Richmond, VA, 23223
9/23/2004
Amicus Separator System Intended for use for the simultaneous collection of platelet concentrate, plasma and red cells BK040059 Baxter Healthcare Corp - Transfusion Therapies Division
Route 120 and Wilson Road
Roundlake, IL 60073
9/24/2004
LOGIC 2.0 Blood Establishment Computer Software BK040040 Fifth Dimension Information Systems
Suite 500, 10025- 102A Avenue
Edmonton, Alberta T5J 2Z2
CANADA
10/6/2004
Check cell (Weak) To confirm the validity of negative Antiglobulin tests obtained with Anti-Human Globulin that contains an anti-IgG components BK040057 Immucor, Inc
3130 Gateway Drive
Norcross, GA 30091-5625
10/6/2004
ACCURUN 315 HIV-1 RNA Positive Control ACCURUN controls are intended to estimate laboratory testing precision and can be used to detect errors in laboratory testing procedures. ACCURUN 315 HIV-1 RNA Positive Quality Control Series [150, 200, 300, 400, 500] is formulated for use with in vitro diagnostic test methods that detect and quantitate HIV-1 RNA. ACCURUN 315 HIV-1 RNA Positive Control Series [150, 200, 300, 400, 500] is designed for a specific range of HIV-1 RNA. Additional controls at different concentrations of HIV-1 RNA are available separately from BBI BK040006 Boston Biomedica, Inc
375 West Street
West Bridgewater, MA 02379
10/12/2004
TRUGENE HIV-1 Genotyping Kit and OpenGene DNA Sequencing System Blood Establishment Computer Software BK040052 Bayer HealthCare Diagnostics Division
700 Bay Street, Suite 1000
Toronto, Ontario M5G 1Z6
Canada
10/15/2004
Quality Donor System 2004 2.0 Blood Establishment Computer Software - Quality Donor System 2004 2.0 - Computerized Donor Self-Administered Health History Questionnaire BK040062 Talisman Ltd
421 Church Street NE, Suite F
Vienna, VA 22180
10/18/2004
LifeTec Donor Verification and Collection System (DOVAC) 1.00 Blood Establishment Computer Software - Life Tec Donor Verification and Collection System (DOVAC) 1.00 - Donor System Software BK040026 SysTec Computer Associates, Inc
28 North Country Road
Mt. Sinai, NY 11766
10/21/2004
Blood Bank Control System (BBCS) 5.0 Blood Establishment Computer Software - Blood Bank Control System, version 5.0 - Donor and Transfusion Services Software BK040056 Blood Bank Computer Systems, Inc
1002 15th SW, Suite 120
Auburn, WA 98001-6502
10/22/2004
Misys Laboratory Blood Bank and Blood Donor 6.0.1 Blood Establishment Computer Software BK040065 Misys Healthcare Systems
4801 East Broadway Boulevard
Tucson, AZ 85711
10/22/2004
Trima Automated Blood Component Collection System - Blood Component Sampling Accessary To allow aseptic removal of a sample from the platelet bag for subsequent bacterial testing BK040069 Gambro BCT, Inc
10811 W. Collins Ave
Lakewood, CO 80215-4498
10/28/2004
ACCURUN 345 HIV-1 RNA, HCV RNA, HBV DNA Positive Quality Control Series 150 External run control to be used with in vitro diagnostic test kits that detect HIV-1 RNA, HCV RNA and HBV DNA BK040064 Boston Biomedica, Inc
375 West Street
West Bridgewater, MA 02379
10/29/2004
Procleix NAT Tracker Software Version 2.1 Blood Establishment Computer Software BK040072 Chiron Corp
4560 Horton St
Emeryville, CA 94608-2916
11/4/2004
Magellan Autologous Platelet Separator System To be used in the clinical laboratory or intraoperatively at the point of care for the safe and rapid preparation of platelet poor plasma and platelet concentrate (platelet rich plasma) from a small sample of a mixture of blood and bone marrow BK040068 Medtronic Sofamor Danek
1800 Pyramid Place
Memphis, TN 38132
11/9/2004
wBlood Care 1.0 Blood Establishment Computer Software BK040002 Care Fusion, Inc
1430 Spring Hill Road, Suite 510
McLean, VA 22102
11/10/2004
Multispot HIV-1/HIV-2 Rapid Test This device is indicated for the detection and differentiation of circulating antibodies associated with HIV-1 and HIV-2 in human plasma and serum, as an aid in the diagnosis of infection with HIV-1 and/or HIV-2 BP040046/0 Bio-Rad Laboratories
6565 185th Avenue NE
Redmond, WA 98052
11/12/2004
ACCURUN 803 Nucleic Acid Negative Quality Control (HIV, HCV, HBV) To be used as an independent, unassayed, external run control with in vitro diagnostic tests for the detection of HIV-1 RNA, HCV RNA and HBV DNA in human serum or plasma BK040067 Boston Biomedica, Inc
375 West Street
West Bridgewater, MA 02379
11/19/2004
Compodock To permit the sterile connection of 2 sterile, standard medical PVC tubing sets BK040076 Fresenius Hemocare Inc
95 Hayden Avenue
Lexington MA 02420
12/17/2004
ACCURUN 305 HCV RNA Positive Quality Control To be used as an independent, unassayed, external run control with in vitro diagnostic tests for the detection of HCV RNA in human serum or plasma BK040016 Boston Biomedica, Inc
375 West Street
West Bridgewater MA 02379
12/17/2004
Haemonetics Model 215 Automated Glycerolization/Deglycerolization System To submit data for a modification to the ACP215 System to support deglycerolization, using the ACP215, of red cells that have been manually glycerolized using the Valeri (40% W/V) method. Permit the sterile connection of 2 sterile, standard medical PVC tubing sets BK040077 Haemonetics Corp
400 Wood Road
Braintree MA 02184
12/21/2004