Experience versatility and accuracy from our LC-MS systems for in vitro diagnostic (IVD) tests and Laboratory Developed Tests (LDTs), which offers clinical diagnostic laboratories a unique choice to address sensitivity needs. Discover mass spectrometry solutions, comprehensive data management, connectivity, and support to help you address any molecule type or matrix complexity with absolute confidence. Our family of LC-MS/MS instruments for in vitro diagnostics deliver greater speed, specificity, and analyte range, along with lower cost per sample.

Benefits of LC-MS for in vitro diagnostic use

Superior specificity, selectivity, sensitivity
Compared to traditional immunoassays, LC-MS enables accurate results, reducing false positives and negatives.

Speed and high throughput capability
Meet analytical needs and budget limitations with the throughput, speed, and sample capacity to boost workflow productivity for laboratory developed tests where analyte resolution is critical.


Comprehensive and flexible
Simultaneous detection of multiple analytes in the same run. Flexible options to meet sensitivity and throughput needs.

Cost Savings and increased productivity
Because the fixed cost of tests decreases when more tests are run, ultra-fast selected reaction monitoring enables detection and quantitation of increased number of analytes, without increasing run times.

Why Choose IVD systems?

Maintain compliance
Hardware manufactured following ISO 13485 and FDA 21 CFR 820; dedicated LDT software for clinical workflow and auditing capability.

Stay up-to-date on regulatory trends
Global clinical diagnostics market trending towards LC-MS devices conforming to FDA and EU regulations to perform LDTs and IVDs.


Control risk
Intensive validation and verification process, MD certified engineer for service, quality tracking in place to ensure the highest performance of instrument.

Benefit from bidirectional connectivity
A middleware software (B-Link) for bidirectional communication between acquisition/data processing software and the Laboratory Information System (LIS).

LC-MS IVD systems

Our LC-MS platform solutions offer flexibility, facilitate cost savings, and enable you to achieve productivity goals, while ensuring confident IVD results.

Software for IVD LC-MS systems

Software is at the heart of the use and accessibility of our mass spectrometry systems. Thermo Scientific TraceFinder software is included with the purchase of our IVD systems for data acquisition and report generation, while optional B-Link bi-directional software creates a direct link between TraceFinder software and the LIS, eliminating time consuming manual errors.

 HPLC System
Vanquish MD
Mass Spectrometers
TSQ Altis MD Series, TSQ Quantis MD Series
Intended UseIntended 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 UseClinical diagnostic laboratories can use as a component of a laboratory developed test (LDT) method or workflow.Clinical diagnostic laboratories can use as a component of a laboratory developed test (LDT) method or workflow.
Contraindications of UseFor 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 UseThermo Scientific instruments: TSQ Altis MD Series and TSQ Quantis MD Series mass spectrometersThermo Scientific instruments: Vanquish MD HPLC

Instrument service and support

Maximize your instrument uptime with superior services and support.

There’s no time for downtime in your lab. Customers worldwide who depend on maximum availability of lab instruments for critical operations choose the Unity Lab Services Premier service plan to minimize disruption and stay focused on production.

Features of the Premier service plan include:

  • Two-business-day, on-site response time for corrective maintenance to minimize downtime
  • Unlimited enhanced technical support with immediate response, featuring remote resolution of more than 35% of issues with our remote repair services
  • Proactive annual preventive instrument maintenance that increases uptime
  • Semiannual service consultations delivered by highly experienced and certified service managers

Learn more 

In Vitro Diagnostic Medical Device

In Vitro Diagnostic Medical Device

 For in-vitro diagnostic use. Specifications subject to change. Availability of product in each country depends on local regulatory marketing authorization status. Not all products are available in all countries. Please consult your local sales representative for details. 

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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