LC-MS Medical Devices for In Vitro Diagnostic Use

Confidence in laboratory developed tests

Our family of liquid chromatography mass spectrometry (LC-MS) instruments for in vitro diagnostics provides clinical labs with consistent reliable results, faster. These comprehensive, reliable LC-MS platform solutions offer greater flexibility than immunoassays, facilitate cost savings and enable clinical laboratories to achieve their productivity goals, while ensuring confidence in results of laboratory developed tests (LDTs).

These Class I LC-MS medical devices leverage the power of a complete software suite conforming to in vitro diagnostic (IVD) requirements and offering an optional laboratory information system (LIS) connection.

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HPLC medical device


Mass spectrometer (MS) medical devices



Software for LC-MS medical devices

TraceFinder LDT Software

TraceFinder LDT Software

For a workflow-oriented approach to high-throughput quantitation, the Class I medical devices are powered by the integral Thermo Scientific TraceFinder LDT software, which is batch-centric and provides a seamless approach to robust, reliable, high throughput quantitation with tools to automate or accelerate the processes of creating methods, loading samples, generating data, manually reviewing and editing results, and finalizing the data review and reporting process.

B-Link Bi-Directional LIS Connection

B-Link® Bi-Directional LIS Connection

Expedited by the optional B-Link LIS/LIMS Connector, B-Link is a Universal LIS/LIMS Connector validated for TraceFinder LDT software. Comprised of a downloadable software package of middleware capable of providing bidirectional communication between TraceFinder software and the Laboratory Information System (LIS), the B-Link LIS/LIMS Connector software is installed on the TSQ Altis MD Series data system or TSQ Quantis MD Series data system—there is no need for any additional hardware.

B-Link Bi-Directional LIS Connection
The B-link LIS/LIMS Connector enables the exchange of compliant LIS system file formats commonly used for test requests and reports.

Intended Use, indications, contraindications and limitations

  HPLC System
Vanquish MD
Mass Spectrometers
TSQ Altis MD Series, TSQ Quantis MD Series
Intended Use General purpose laboratory instruments intended to separate drugs or compounds in human specimens. For in vitro diagnostic use only by trained, qualified laboratory personnel. Intended to identify and quantify inorganic and organic compound in human specimens. For in vitro diagnostic use only by trained, qualified laboratory personnel.
Indications for Use Used by clinical diagnostic laboratories as a component of a laboratory developed test (LDT) method or workflow. Used by clinical diagnostic laboratories as a component of a laboratory developed test (LDT) method or workflow.
Contraindications of Use For in vitro diagnostic applications only. The Vanquish MD HPLC is to be operated only with hardware or software approved for in vitro diagnostic application. For in vitro diagnostic applications only. The TSQ Altis MD Series and TSQ Quantis MD Series mass spectrometers are to be operated only with hardware or software labeled for in vitro diagnostic use.
Limitations of Use Compatible with the following Thermo Scientific instruments: TSQ Altis MD Series and TSQ Quantis MD Series mass spectrometers. Compatible with the following Thermo Scientific instruments: Vanquish MD HPLC.

For in-vitro diagnostic use. Specifications subject to change. Availability of product in each country depends on local regulatory marketing authorization status.

This information is presented as an example of the capabilities of Thermo Fisher Scientific products. It is not intended to encourage use of these products in any manner that might infringe the intellectual property rights of others. Specifications, terms and pricing are subject to change.

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