Vaccines, Blood & Biologics
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2009 Biological Device Application Approvals
This list reflects information regarding the applications as of the approval/clearance date. It is not updated with regard to applicant or application status changes. The applications are listed in order by date of approval / clearance.
| Tradename | Description and Indication for Device | Number | Applicant | Approval Date |
|---|---|---|---|---|
| TRUGENE HIV-1 Genotyping Kit and OpenGene DNA Sequencing System |
Blood Establishment Software | BK090077 | Siemens Healthcare Diagnostics Inc. P.O. Box 2466 Berkeley, CA 94702 |
12/28/2009 |
| Sanguin Aurora version 2.0 | Blood Establishment Software | BK090061 | Sanguin International 1020 Sherman Avenue Hamden, CT 06514 |
12/22/2009 |
| VITROS Immunodiagnostics Products Anti-HIV 1+2 Calibrator and Reagent Pack |
HIV Detection Test | BP050051/019 | Ortho-Clinical Diagnostics, Inc 100 Indigo Creek Drive Rochester, NY 14626-5101 |
12/10/2009 |
| InterSol Solution | For the storage of apheresis platelets for up to 5 days | BN080041 | Fenwal Inc Three Corporate Drive 2nd Floor Lake Zurich, IL 60047 |
12/9/2009 |
| Integrated Blood Bank Information System | Blood Establishment Software | BK090064 | LifeSouth Community Blood Centers Inc. 4039 W. Newberry Road Gainesville, FL 32607 |
12/8/2009 |
| Test Result Interface for ElDorado Donor | An adjunct device to ElDorado Donor, aiding in the transfer of test results for donor samples and components into the ElDorado Donor database. The Test Result Interface is intended to receive, parse, validate, and translate testresults from testing analyzers or facilities | BK090063 | Wyndgate Technologies 4925 Robert J. Matthews Parkway Suite 100 El Dorado Hills, CA 95762 |
11/20/2009 |
| ADVIA Centaur HIV 1/O/2 Enhanced ReadyPack Reagents |
An in vitro diagnostic immunoassay for the qualitative determination of antibodies to the human immunodeficiency virus type 1, including group O, and/or type 2 in serum or plasma using the ADVIA Centaur System. | BP050030/008 | Siemens Medical Solutions Diagnostics 511 Benedict Ave. Tarrytown, NY 10591 |
11/19/2009 |
| ADVIA Centaur HIV 1/O/2 Enhanced ReadyPack Reagents |
An automated immunoassay analyzer designed to perform in vitro diagnostic immunochemical assay analysis on clinical specimens.The system menu includes endocrine, anemia, allergy, reproductive, cardiovascular,
|
BP050030/010 | Siemens Medical Solutions Diagnostics 511 Benedict Ave. Tarrytown, NY 10591 |
11/13/2009 |
| Sunrise Blood Bank version2.0 SP2 | Blood Establishment Software | BK090044 | Eclypsis Corporation 450 Lapp Road Malvern, PA 19355 |
11/13/2009 |
| Platelet PGD Test System | Bacterial Detection Systems for Platelet Transfusion Products |
BK090028 | Verax Biomedical Incorporated 377 Plantation St., Biotech 4 Worcester, MA 01605 |
11/10/2009 |
| ElDorodo Donor Doc | Blood Establishment Software | BK090033 | Wyndgate Technologies 4925 Robert J. Matthews Parkway Suite 100 El Dorado Hills, CA 95762 |
10/28/2009 |
| VITROS Immunodiagnostics Products Anti-HIV 1+2 Calibrator and VITROS Immunodiagnostics Products Anti-HIV 1+2 Reagent Pack | HIV Detection Test | BP050051/018 | Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Dr. Rochester, NY 14626-5101 |
10/9/2009 |
| Symphony System | Blood Establishment Software | BK090041 | Haemonetics Corporation 400 Wood Road Braintree, MA 02184-9114 |
9/28/2009 |
| To be used in the clinical laboratory or intra-operatively at point-of-care for the safe and rapid preparation of plasma and platelet concentrate from a small sample of blood | BK080057 | Kaylight Corporation 602 Anacapa Irvine, CA 92602 |
9/25/2009 | |
| Avioq HIV-1 Microelisa System | HIV Detection Test | BP090022 | Avioq, Inc. 9700 Great Seneca Hwy. Rockville, MD 20850 |
9/21/2009 |
| Olerup SSP HLA Typing Kits | Qualitative in vitro diagnostic kits for the DNA typing Class I and Clas II HLA Allelles | BK090042 | Olerup SSP AB Hasselstigen 1 SE 133 33 Saltsjobaden Sweden |
9/11/2009 |
| Sysmex XE-2100D and XS-1000i | Automated Hematology Analyzers intended for in vitro diagnostic use in clinical laboratories as multi-parameter hematology analyzers using EDTA anticoagulant and in blood centers using anticoagulants (CPD, CPD2, ACD-A, CDPA-1) commonly used in non-whole blood products for red blood cells and platelets. | BK080067 |
Sysmex America, Inc. |
9/8/2009 |
| Safe Trace Tx | Blood Establishment Computer Software |
BK090026
|
Wyndgate Technologies
|
9/3/2009 |
| Donor Information System (DIS) version 4.0 | Blood Establishment Computer Software | BK090001 | BioLife Plasma Services LP One Baxter Pkwy Deerfield, IL 60015 |
8/18/2009 |
| Bone Marrow Collection Kit and Accessories | Used for collection and filtration of aspirated bone marrow in preparation for bone marrow transplantation. | BK090031 | Fenwal Inc Three Corporate Drive 2nd Floor Lake Zurich, IL 60047 |
7/23/2009 |
| Biomixer BM330 with XBee (Wireless) Option | For use by a trained medical professional for blood collection and data registration. | BK090010 | Ljungberg & Kogel C/O Kamm & Associates 333 Milford Rd. Deerfield, IL 60015 |
7/17/2009 |
| Control Cells | Used for quality control of the antiglobulin test performed with Anti-Human Globulin containing ani-IgG. | BK090021 | American Red Cross Diagnostic Manufacturing Division 2025 E St. NW Washington, DC 20006 |
6/24/2009 |
| SoftBank II Version 25 - 25 |
Blood Establishment Computer Software |
BK090017 | SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760 |
6/23/2009 |
| Donor-ID Web 3.1.4 |
Blood Establishment Computer Software |
BK080044 | Healthcare-ID 1635 Barclay Blvd. Buffalo Grove, IL 60089 |
6/10/2009 |
| AutoFusion v3.02 |
Blood Establishment Computer Software |
BK080047 | SofTov Ltd 32 HaShacham St. 49517 Petach Tikva, Israel |
6/5/2009 |
| LIFECODES Evolution Software, version 1.0 |
An accessory for the evaluation of test results from Tepnel Lifecodes' antibody screening products. |
BK090018 | Tepnel Lifecodes Corporation 550 West Avenue Stamford, CT 06902 |
6/4/2009 |
| ORTHO ProVue, version 3.1 | A modular, microprocessor-controlled instrument designed to automate in vitro immuno-hematological testing of human blood utilizing the ID-MTS/Gel Technology. As a standalone instrument or interfaced to the customer's Laboratory Information System (LIS), ProVue automates test processing functions and data management requirements using gel cards and digital image. |
BK090013
|
Micro Typing Systems Inc. 1295 S.W. 29th Ave. Pompano Beach, FL 33069 |
6/4/2009 |
| Ortho Summit System | Pipetting of Enzyme linked immunosorbent assays (ELISA), including licensed blood screening tests distributed by OCD. | BK090074 | Ortho-Clinical Diagnostics, Inc. 1001 U.S. Highway 202 P.O. Box 350 Raritan, NJ 08869-0606 |
5/27/2009 |
| Morgan HLA SSP ABCDRDQ Typing Kit | An in vitro diagnostic medical device, intended for providing the HLA-A, B, C, DRB and DQB typing results with a low to medium resolution by DNA based method. | BK080039 | Texas BioGene, Inc. 635 Presidential Dr Richardson, TX 75081 |
4/22/2009 |
| Lifecodes LifeScreen Deluxe | A qualitative test that can be used to detect the presence of IgG antibodies produced in patients sensitized to HLA by transfusion, pregnancy, or tissue transplantation. This kit is intended for in vitro diagnostics (IVD) use. | BK090002 | Genetic Testing Institute, Inc. (GTI) 20925 Crossroads Circle Suite 200 Waukesha, WI 53186 |
4/17/2009 |
| LABScreen Multi DBA | Used for the detection of antibodies to human leukocyte antigens | BK080071 | One Lambda, Inc. 21001 Kittridge St. Canoga Park , CA 91303 |
4/10/2009 |
| FETALSCREEN™ II |
A qualitative screening test for RhD (Rho) positive fetal red blood cells in the maternal circulation |
BK080051 | Alba Bioscience 21 Ellen's Glen Road Liberton, Edinburgh EH17 7QT Scotland , UNITED KINGDOM |
4/8/2009 |
| Sunquest Blood Bank Donor 6.4 | Provides a complete transfusion service with autologous/ directed capabilities and inventory control. A permanent patient file allows for automatic retrieval of patient records, and applicable reports can be generated along with automatic capture of workload statistics. Billing information can be sent automatically to the hospital financial system | BK080042 | Sunquest Information Systems Inc. 250 S. Williams Blvd. Tucson , AZ 85711 |
3/3/2009 |
| Pall Acrodose PL System |
To be used to pool and store whole-blood-derived, Leukocyte-reduced platelets in the CLX HP | BK090007 | Medsep Corporation 1630 Industrial Park Covina, CA 91722 |
2/25/2009 |
| MCS+8150 System - Wireless | The MCS+ 8150 with wireless capable modification may be used to collect the following blood components from allogeneic and autologous donors | BK090004 | Haemonetics Corporation 400 Wood Road Braintree MA 02184 -9144 |
2/20/2009 |
| Olerup SSP HLA Typing Kits | Qualitative in vitro diagnostic kits for the DNA typing of Class I and II HLA alleles. The products are used by trained professionals in medical settings for the purpose of determining HLA phenotype. The source material tested is DNA | BK080022 | Olerup SSP AB Hasselstigen 1 SE 133 33 Saltsjobaden Sweden |
2/20/2009 |
| Pall eBDS | For use with the Pall eBDS Oxygen Analyzer in qualitative procedures for the recovery and detection of aerobic and facultative anaerobic microorganisms for quality control testing of apheresis and single and pooled units of whole-blood-derived platelet products. | BK080014 | Pall Life Sciences 25 Harbor Park Dr North Port Washington , NY 11050-4630 |
2/13/2009 |
| Automated Blood Bank Analyzer | The Galileo is microprocessor-controlled instrument designed to fully automate immunohematology in vitro diagnostic testing of human blood. | BK080070 | Immucor, Inc. 3130 Gateway Drive Norcross , GA 30091-5625 |
2/5/2009 |
| SoftDonor 4.5 | Intended to be a decision support system used by knowledgeable users to document steps in the manufacture of blood and blood components. The software also maintains that data which blood center personnel use in making decisions regarding the suitability/deferral of donors and the release of blood or blood for transfusion purposes or for further manufacture | BK080069 | SCC Soft Computer 5400 Tech Data Drive Clearwater , FL 33760 |
1/16/2009 |
| TRUGENE® HIV-1 Genotyping Kit and OpenGene® DNA Sequencing System | The TRUGENE HIV-1 Genotyping Kit and the OpenGene DNA Sequencing System is indicated for use in detecting HIV genomic mutations in the protease and part of the reverse transcriptase regions of HIV that confer resistance to specific types of antiretroviral drugs, as an aid in monitoring and treating HIV infection. | BK080073 | Siemens Medical Solutions Diagnostics P.O. Box 2466 Berkeley , CA 94702-0466 |
1/15/2009 |
| Leucolab LCG2 Leukoreduction System for AS-1, AS-3, and AS-5 Red Blood Cells | Indicated for the leukoreduction of a single unit of AS-1 and AS-3 red cells, at room temperature (20 to 24°C) within 8 hours of collection, or AS-1, AS-3, and AS-5 red cells at 1 to 6° C up to 3 days after collection . | BK080060 | MacoProductions S.A.S. 1733 Canton Lane, Suite 103 Marietta , GA 30062-2679 |
1/14/2009 |
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