LC-MS Medical Devices for in vitro Diagnostics

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LC-MS Medical Devices for In Vitro Diagnostic Use

Increase efficiency, throughput, and cost savings— performing laboratory developed tests (LDTs) and in vitro diagnostic (IVD) assays by liquid chromatography-mass spectrometry.

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GET YOUR COPY: 5 REASONS TO 

IMPLEMENT LC-MS FOR LDTs

Vanquish MD HPLC System
Better separation, accuracy, and ease-of-use

TSQ Altis MD Series mass spectrometer
Enhanced sensitivity with remarkable speed and
robustness for laboratory developed tests

Increase efficiency, productivity, and cost savings

Our comprehensive LC-MS platform enables accurate results, facilitates cost savings, and allows clinical laboratories to achieve organizational and scientific goals while ensuring confidence in results of LDTs.
5 Reasons to Implement LC-MS for LDTs

TSQ Quantis MD Series mass spectrometer
IVD compliance with sensitivity, remarkable speed,
and robustness for routine laboratory developed tests

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

PORTFOLIO SUMMARY

Ease, efficiency, and flexibility for laboratory developed tests

Benefits of choosing LC-MS for LDTs

Superior specificity, selectivity, sensitivity

Compared to traditional immunoassays, LC-MS enables accurate results, thus reducing false positives or negatives.

Fast speed and high throughput capability

Enable faster turnaround time in clinical laboratories

Comprehensive and flexible

Allows spontaneous detection of multiple analytes
in the same run

Cost savings and increased productivity

Compared with immunoassay, LC-MS methodology reduces costs associated with testing kits and consumables and sample and potential labor costs

Reasons to Choose Class I Medical Devices

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Compliance

Hardware manufactured follows ISO 13485 and FDA 21 CFR 820 standards; dedicated, integral LDT software for clinical workflow and auditing capability

Reasons to Choose Class I Medical Devices

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Regulatory Trends

Global clinical diagnostics market is trending towards LC-MS devices conforming to FDA and EU regulation to perform LDTs

Reasons to Choose Class I Medical Devices

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Connectivity

A middleware software (B-Link® Universal LIS/LIMS Connector)
for bidirectional communication between acquisition/data processing software and the Laboratory Information System (LIS)

Reasons to Choose Class I Medical Devices

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Risk Control

Thorough validation and verification process; Medical device-certified engineer for service; Quality tracking in place to ensure the highest instrument performance

Take a Medical Device Tour with Kristine and Stephanie!

Are You Navigating the IVDR Landscape?

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IMPLEMENT LC-MS FOR LDTs

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Want to Learn More? Speak to an Expert.

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

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