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Autologous Platelet System - PRFM
Musculoskeletal Transplant Foundation, Inc.
910050
Not in Commercial Distribution
- 00859070006036 ()
910050
- Haematological concentrate system preparation kit, platelet concentration
Autologous Platelet System - PRP X 2
Musculoskeletal Transplant Foundation, Inc.
910047
Not in Commercial Distribution
- 00859070006029 ()
910047
- Haematological concentrate system preparation kit, platelet concentration
Autologous Platelet System Membrane
Musculoskeletal Transplant Foundation, Inc.
910044
Not in Commercial Distribution
- 00859070006012 ()
910044
- Haematological concentrate system preparation kit, platelet concentration
Autologous Platelet System - RPR
Musculoskeletal Transplant Foundation, Inc.
910046
Not in Commercial Distribution
- 00859070006005 ()
910046
- Haematological concentrate system preparation kit, platelet concentration
IgG-coated red blood cells used to confirm negative results in direct antiglobulin test (DAT) and indirect antiglobulin test (IAT).
AMERICAN NATIONAL RED CROSS
510400/510402
In Commercial Distribution
- 20858400005095 ()
- 00858400005091 ()
- 10858400005098 ()
- Immunoglobulin-sensitized reagent red blood cell IVD, control
Blood Bank kit used to perform quality control testing of reverse grouping and screening cell reagent red blood cells.
AMERICAN NATIONAL RED CROSS
510395
In Commercial Distribution
- 00858400005084 ()
- Multiple immunohaematology test IVD, control
No Description
MEDHOST OF TENNESSEE, INC.
9.0
In Commercial Distribution
- 00869202000214 ()
- Blood bank information system application software
The LifeTec Elite system is a blood establishment computer system that receives and stores data in the manufacture of blood and blood components, which blood establishments rely on for making decisions regarding the release of blood components for transfusion or further manufacturing. Specifically, laboratory testing, product manufacturing and inventory control/distribution.
IT SYNERGISTICS, LLC
1.0
In Commercial Distribution
- 00867268000414 ()
- Blood bank information system application software
The DoVac Elite system is a web-based application that provides functions for managing donors, donations and the collection process. The system identifies results and responses throughout the process that can be considered ‘high-risk’ to the general blood supply which notifies and allows a staff member to complete a review to determine donor suitability. The DoVac Elite application is capable of capturing all information in the collection process: registration, physical exam, computer assisted medical questionnaire, donor consent, donation identification number assignment, phlebotomy, supervisor review and audit. The system maintains a complete record of all interactions throughout including the donation process, device interfaces, auditing and donor/donation maintenance functions.
IT SYNERGISTICS, LLC
2.0
In Commercial Distribution
- 00867268000407 ()
- Blood bank information system application software
The Procleix Software is one part of the Procleix Xpress System. The Procleix Xpress System (software and instrument) is intended to be used to create pools of human plasma or serum for blood screening tests for viral nucleic acids. The Procleix Xpress System automatically transfers plasma or serum from individual samples into a single master pool tube, which may be used for further testing in Procleix systems. The Procleix Xpress System also collects barcode data from all tubes, racks, and archive plates used in a given pooling run, establishing positive specimen identification and Master Pool Tube (MPT) composition. In addition, the Procleix Xpress System can be used to dispense human plasma or serum aliquots into an archive plate.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Version 3.0
In Commercial Distribution
- 00866489000036 ()
740769
- Pipetting system
The Procleix Pipettor is one part of the Procleix Xpress System. The Procleix Xpress System is intended to be used to create pools of human plasma or serum for in vitro diagnostic testing, such as blood screening tests for viral nucleic acids. The Procleix Xpress System automatically transfers plasma or serum from individual samples into a single master pool tube, which may be used for further testing in Procleix systems. The Procleix Xpress System also collects barcode data from all tubes, racks, and archive plates used in a given pooling run, establishing positive specimen identification and Master Pool Tube (MPT) composition. In addition, the Procleix Xpress System can be used to dispense human plasma or serum aliquots into an archive plate.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
30055067
In Commercial Distribution
- 00866489000005 ()
30055067
- Electronic pipette
The Genesis RapidWeld II STW, model GRW-430-02, is a medical device used in laboratories, designed for the purpose of making sterile connections in PVC tubing in blood processing applications. The device enables fluid transfer while maintaining a closed system without the need for a consumable (disposable wafer).
GENESIS BPS LLC
GRW-430-02
In Commercial Distribution
- 00866305000264 ()
- Length: 33 Centimeter
- Height: 9.9 Centimeter
- Width: 14.2 Centimeter
- Weight: 2.5 Kilogram
480-RW-2607-02
- Laboratory tubing welder
The Genesis Rapid Weld STW is a medical device used in laboratories, designed for the purpose of making sterile connections in PVC tubing in blood processing applications. The device enables fluid transfer while maintaining a closed system without the need for a consumable (disposable wafer).
GENESIS BPS LLC
GRW-430
In Commercial Distribution
- 00866305000202 ()
- Weight: 2.5 Kilogram
- Width: 14.2 Centimeter
- Height: 9.9 Centimeter
- Length: 33 Centimeter
480-RW-2607-00
- Laboratory tubing welder
MEDITECH's Blood Bank application tightly integrates donor, unit, and patient history information with data in the health care information system (HCIS). The application flags abnormal test results, reports test and transfusion results, minimizes product waste, utilizes expert rules when recording, and performs error checks. It also generates turnaround time and workload statistics, compiles statistical reports, and automatically captures charges. Authorized users have the ability to view blood bank results from within the network or remotely. All of these features ensure patient safety and reduce turnaround times.
MEDICAL INFORMATION TECHNOLOGY, INC.
Magic
In Commercial Distribution
- 00863529000100 ()
- Blood bank information system application software
This is the outer label for the box that includes 12 3C Patch® Kits and the IFU.
Reapplix ApS
2
In Commercial Distribution
- 05714188505503 ()
- Haematological concentrate system preparation kit, platelet concentration
This is the retail bag label for the retail bag, which contains 6 venipuncture needle sets (commercially available) and 6 3C Patch Needle Holders.
Reapplix ApS
2
In Commercial Distribution
- 05714188505206 ()
- Haematological concentrate system preparation kit, platelet concentration
Kit that includes 3C Patch Device, 3C Patch Needle Holder, Venipuncture Needle Set (commercially available), Skin Preparation Alcohol Swab (commercially available), Post-Sampling Adhesive Bandage (band aid) (commercially available), and Primary Wound Cover Dressing (commercially available).
Reapplix ApS
2
In Commercial Distribution
- 05714188505008 ()
- Haematological concentrate system preparation kit, platelet concentration
Holds the blood at collection and during processing in the centrifuge.
Reapplix ApS
2
In Commercial Distribution
- 05714188502106 ()
- Haematological concentrate system preparation kit, platelet concentration
Used to attach and hold the 3C Patch Device with the supplied venipuncture set.
Reapplix ApS
2
In Commercial Distribution
- 05714188501000 ()
- Haematological concentrate system preparation kit, platelet concentration
ADIMS is a stand-alone blood establishment computer software application (BECS) that provides for the management of plasma and whole blood donors for an RBC immunization program as well as the record and inventory management of immunogen red blood cells. The application is used to determine donor eligibility and release of the blood or blood component for transfusion as well as tracking the preparation of immunogen components (vials) for storage and distribution. Additionally, ADIMS allows for the tracking the recipient of transfused immunogen RBCs
Csl Plasma Inc.
1.0
In Commercial Distribution
- 00860007397615 ()
- Blood bank information system application software
LOGIC 4.0 is a web-based software application used to support daily operations of product logistics, primarily organizing and controlling the movement of plasma units between facilities such as warehouses and fractionators. The application also communicates observations or post donation information, status and recalls between collection, warehouse and fractionation facilities. LOGIC provides interface capabilities with sub-systems.
Csl Plasma Inc.
4.0
In Commercial Distribution
- 00860007397608 ()
- Blood bank information system application software
e-Delphyn LIS 21.x.x (US)
Gpi Usa, Inc.
21.x.x (US)
In Commercial Distribution
- 00860007282744 ()
- Blood bank information system
Surround 5.x
Gpi Usa, Inc.
5.x
- Blood bank information system
Donor Doc 3.x.x
Gpi Usa, Inc.
3.x.x
- Configurable electronic form web-based application software
ElDorado Donor 3.x.x
Gpi Usa, Inc.
3.x.x
- Blood bank information system
Regulated Software Application (RSA), Version 2.0 is a stand-alone blood establishment computer software application (BECS) that provides management controls and information services that have been designed to assist personnel in the operation of a blood center.
ARC-ONE SOLUTIONS, LLC
2.0.0.0
In Commercial Distribution
- 00860006793708 ()
2.0.0.0
- Blood bank information system application software
The Regulated Software Application (RSA) is a system of co-dependent web based computer programs, used to manage and support all aspects of the blood banking process.
ARC-ONE SOLUTIONS, LLC
1.0.33.0
Not in Commercial Distribution
- 00860003545409 ()
1.0.33.0
- Blood bank information system application software
AuraGen 1-2-3 with AuraClens - Lipoaspirate Wash System
Auragen Aesthetics LLC
100358
In Commercial Distribution
- 00860003492703 ()
- Autologous adipose tissue collection/washing set
Software, blood bank, stand alone product
CIRDAN IMAGING LIMITED
4.1
In Commercial Distribution
- 05060508820031 ()
- Blood bank information system application software
ORTHO CONNECT™ Software is designed to collect data from the Ortho Clinical Diagnostics blood typing instruments and its proprietary immunohematology reagent system, which allows operators to track individual patient and donor samples and link them to the appropriate test results. The software collates the results from testing, assigns outcomes to individual samples according to configured rules, and formats output files that can be sent to a Laboratory Information Management System (LIMS).
ORTHO CONNECT™ Software is intended to be used by Blood Establishments and by personnel who are trained in its operation.
BIOMEDICAL DATA SOLUTIONS LIMITED
3.0
In Commercial Distribution
- 05060496770066 ()
- Laboratory instrument/analyser application software IVD
The Liberty SRIMPORT software is an interface that is part of the SRIMPORT functionality to import data through a file based transmission. Its intended use is to import results from laboratory instruments, typically chemistry and special chemistry analysers. The interface module contains no interpretation algorithms and serves as a library functions to consolidate pre-determined results from external instruments. The Liberty SRIMPORT Software's indicated use is in the Blood Bank, Donor Centre and Plasma Testing Laboratories as well as Clinical Diagnostic and Screening Laboratories. It may be applied to a group of laboratory instruments that export test results to another device.
BIOMEDICAL DATA SOLUTIONS LIMITED
3.1
In Commercial Distribution
- 05060496770059 ()
- Blood bank information system application software
ORTHO CONNECT™ Software is designed to collect data from blood grouping and immunology assays, which allows operators to track individual patient and donor samples and link them to the appropriate test results. The software collates the results of testing, assigns outcomes to individual samples according to a configured rule, and formats output files that can be sent to a Laboratory Information Management System (LIMS).
BIOMEDICAL DATA SOLUTIONS LIMITED
2.0
In Commercial Distribution
- 05060496770028 ()
- Blood bank information system application software
Procleix NAT Manager Software is designed to collect data from Procleix assays, instruments, and pooling/lysis software, which allows operators to track individual donor blood samples and link them to the appropriate test results. The software collates the results of lysing, pooling and testing, assigns outcomes to individual samples according to a testing algorithm, and formats output files that can be sent to a Laboratory Information Management System (LIMS). Procleix NAT Manager Software also produces a variety of summary informational and analytical reports.
BIOMEDICAL DATA SOLUTIONS LIMITED
1.2
In Commercial Distribution
- 05060496770011 ()
- Blood bank information system application software
cobas Synergy Software is software which controls pre-analytic instruments used to manage tubes and pipette liquid sample material to form pools of samples, as a front-end to the cobas® 6800/8800 Systems. cobas Synergy Software is intended for use in plasma fractionation and whole blood testing laboratories. The software is intended to be used by personnel who are trained in its operation and are familiar with the associated assays and instruments.
BIOMEDICAL DATA SOLUTIONS LIMITED
1
In Commercial Distribution
- 05060496770004 ()
- Blood bank information system application software
HIV-1/2 Antibody Test Controls (Test Controls) are external quality control agents intended for use only with Reveal G4. These Test Controls should be used in conjunction with Good Laboratory Practices in laboratories that have established an adequate quality assurance program, including planned systematic activities to provide adequate confidence that requirements for quality will be met.
MedMira Laboratories Inc
815311007590
In Commercial Distribution
- 00628451188209 ()
- HIV1/HIV2 antibody IVD, kit, rapid ICT, clinical
Reveal G4 Rapid HIV-1/2 Antibody Test (Reveal G4) is a single use, qualitative immunoassay to detect antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and Human Immunodeficiency Virus Type 2 (HIV-2) in human whole blood (venipuncture and fingerstick), serum, and plasma. Reveal G4 is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1 and/or HIV-2. This test is suitable for use in multi-test algorithms designed for statistical validation of rapid HIV test results. When multiple rapid tests are available, this test should be used in appropriate multi-test algorithms.
MedMira Laboratories Inc
815311000591
In Commercial Distribution
- 00628451188193 ()
- HIV1/HIV2 antibody IVD, kit, rapid ICT, clinical
Reveal G4 Rapid HIV-1/2 Antibody Test (Reveal G4) is a single use, qualitative immunoassay to detect antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and Human Immunodeficiency Virus Type 2 (HIV-2) in human whole blood (venipuncture and fingerstick), serum, and plasma. Reveal G4 is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1 and/or HIV-2. This test is suitable for use in multi-test algorithms designed for statistical validation of rapid HIV test results. When multiple rapid tests are available, this test should be used in appropriate multi-test algorithms.
MedMira Laboratories Inc
815311007576
In Commercial Distribution
- 00628451188186 ()
- HIV1/HIV2 antibody IVD, kit, rapid ICT, clinical
Reveal® G4 Rapid HIV-1/2 Antibody Test (Reveal® G4) is a single use, qualitative immunoassay to detect antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and Human Immunodeficiency Virus Type 2 (HIV-2) in human whole blood (venipuncture and fingerstick), serum, and plasma. Reveal® G4 is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1 and/or HIV-2. This test is suitable for use in multi-test algorithms designed for statistical validation of rapid HIV test results. When multiple rapids tests are available, this test should be used in appropriate multi-test algorithms.
MedMira Laboratories Inc
815311007583
In Commercial Distribution
- 00628451188179 ()
- HIV1/HIV2 antibody IVD, kit, rapid ICT, clinical
No Description
BSL Co.,Ltd
ACPU-100
In Commercial Distribution
- 08800080260026 ()
- 08800080260019 ()
- Autologous adipose tissue collection/injection set
No Description
BSL Co.,Ltd
SKT-SS-100
In Commercial Distribution
- 08800080211028 ()
- 08800080211011 ()
- 08800080211035 ()
- Autologous adipose tissue collection/injection set
No Description
BSL Co.,Ltd
SKT-AN-40201
In Commercial Distribution
- 08800080202224 ()
- Autologous adipose tissue collection/injection set
No Description
BSL Co.,Ltd
SKT-AN-24201
In Commercial Distribution
- 08800080202217 ()
- Autologous adipose tissue collection/injection set
No Description
BSL Co.,Ltd
SKT-AN-6020
In Commercial Distribution
- 08800080202200 ()
- Autologous adipose tissue collection/injection set
No Description
BSL Co.,Ltd
SKT-AN-1240
In Commercial Distribution
- 08800080202194 ()
- Autologous adipose tissue collection/injection set
No Description
BSL Co.,Ltd
SKT-AN-2460
In Commercial Distribution
- 08800080202187 ()
- Autologous adipose tissue collection/injection set
No Description
BSL Co.,Ltd
SKT-AN-4001
In Commercial Distribution
- 08800080202170 ()
- Autologous adipose tissue collection/injection set
No Description
BSL Co.,Ltd
SKT-AN-2401
In Commercial Distribution
- 08800080202163 ()
- Autologous adipose tissue collection/injection set
No Description
BSL Co.,Ltd
SKT-AN-1201
In Commercial Distribution
- 08800080202156 ()
- Autologous adipose tissue collection/injection set
No Description
BSL Co.,Ltd
SKT-AN-601
In Commercial Distribution
- 08800080202149 ()
- Autologous adipose tissue collection/injection set
No Description
BSL Co.,Ltd
SKT-AN-401
In Commercial Distribution
- 08800080202132 ()
- Autologous adipose tissue collection/injection set