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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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No Description
ALLIANCE PARTNERS LLC
CYC-120-02
In Commercial Distribution

  • M686CYC120020 ()
CYC-120-02

  • Haematological concentrate system
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
ALBAcyte IgG Sensitized Red Blood Cells for control of the direct and indirect antiglobulin test.
ALBA BIOSCIENCE LIMITED
Z441U
In Commercial Distribution

  • 05060242471162 ()


  • Immunoglobulin-sensitized reagent red blood cell IVD, control
No Description
Thermo Electron LED GmbH
CW3 Cell Washer
Not in Commercial Distribution

  • 10850685007002 ()
75007504

  • Cell washer IVD
Blood mixing and weighing device
Transmed Medizintechnik GmbH & Co. KG
TRANSWAAG PRO
In Commercial Distribution

  • 04028339620139 ()
97.8700.105

  • Blood weighing scale
No Description
MAK-SYSTEM GROUP LIMITED
v5.0.3
In Commercial Distribution

  • 03665324000050 ()


  • Blood bank information system
No Description
MAK-SYSTEM GROUP LIMITED
5.0.1
In Commercial Distribution

  • 03665324000036 ()


  • Blood bank information system
No Description
MAK-SYSTEM GROUP LIMITED
v2.0
In Commercial Distribution

  • 03665324000005 ()


  • Blood bank information system
For Filtration and Storage of One Unit of ACD-A/ADSOL Red Blood Cells. Sterile Fluid Path.
Fresenius Kabi AG
4C2304
In Commercial Distribution

  • M5264C23041 ()
  • M5264C23040 ()
  • M5264C23043 ()
4C2304

  • Blood transfer set
Assayed Quality control solution
Eurotrol B.V.
188.003.002
In Commercial Distribution

  • 08718734960409 ()
  • 08718734960416 ()
188.003.002

  • Total haemoglobin (totHb) IVD, control
Assayed Quality control solution
Eurotrol B.V.
188.002.002
In Commercial Distribution

  • 08718734960386 ()
  • 08718734960393 ()
188.002.002

  • Total haemoglobin (totHb) IVD, control
Assayed Quality control solution
Eurotrol B.V.
188.001.002
In Commercial Distribution

  • 08718734960362 ()
  • 08718734960379 ()
188.001.002

  • Total haemoglobin (totHb) IVD, control
No Description
Regenlab USA LLC
RK-BCT-3
Not in Commercial Distribution

  • 08500331310066 ()


  • Haematological concentrate system preparation kit, platelet concentration
No Description
Regenlab USA LLC
A-CP-3
Not in Commercial Distribution

  • 08500331310011 ()


  • Haematological concentrate system preparation kit, platelet concentration
The ID CORE CONTROL kit consists of 2 sets of recombinant synthetic DNA plasmids to be used as positive controls to evaluate the performance of the ID CORE XT test(Kit Product Number: 1021720000). The ID CORE CONTROL kit contains two separate vials: ID CORE CONTROL 1 and ID CORE CONTROL 2, both composed of synthetic plasmid pools to be used as assayed positive controls for alternate alleles (alleles 1 and 2, respectively) of the 29 polymorphisms assayed by ID CORE XT. Both control vials must be used in every run of the ID CORE XT test as positive controls for the correct detection of the polymorphism genotypes interrogated by the test. Each control has expected polymorphism genotypes results in the ID CORE XT test when analyzed by the ID CORE XT ANALYSIS SOFTWARE and will produce a valid or invalid run result. ID CORE XT is a qualitative, polymerase chain reaction (PCR) and hybridization-based genotyping test for the simultaneous identification of multiple alleles encoding human erythrocyte antigens (HEAs) in human genomic DNA. ID CORE XT interrogates 29 polymorphisms to predict 53 HEA allele genotypes and 37 antigen phenotypes of the following blood group systems: Rh, Kell, Kidd, Duffy, MNS, Diego, Dombrock, Colton, Cartwright and Lutheran, as an alternative to serology.
PROGENIKA BIOPHARMA, SA
v1
In Commercial Distribution

  • 08437013457040 ()
1301790000

  • Multiple blood group genotyping IVD, control
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