Biomedical Data Solutions Limited

FDA Registration(s)#

Registered Device Listings#

GUDID#

• Ortho Connect - 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

  2020-11-18

• cobas Synergy - 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

  2018-09-18

• Procleix NAT Manager - 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

  2018-10-02

• ORTHO CONNECT - 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

  2018-10-02

• Sanguin Aurora - Sanguin Aurora 2.0 is indicated for use in Clinical Diagnostic Laboratories, Blood Bank and Blood Establishments where it captures test and result data from laboratory equipment. It can be applied to single tests or a panel of tests that are used to screen blood donation (whole blood or plasma) as a pre-requisite to transfusion. Typically these tests would include markers such as Hepatitis Markers and HIV and may include non-viral testing such as ABO and Rhesus confirmation of donors, patient typing and antibody screening.

  BIOMEDICAL DATA SOLUTIONS LIMITED

  2018-10-23

• Sanguin Liberty SRIMPORT - 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

  2018-10-29