Develop in vitro diagnostic tests for demanding quantitative analyses leveraging the enhanced sensitivity and remarkable speed and robustness of the Thermo Scientific™ TSQ Altis™ MD Series Mass Spectrometer. The TSQ Altis MD Series mass spectrometer, a Class I medical device, offers superb analytical performance and features the maximum usability, sensitivity and robustness required for laboratory developed tests (LDTs) from clinical diagnostic laboratories. With superb analytical performance, this platform features maximum usability, sensitivity, and robustness.
The TSQ Altis MD Series mass spectrometer is intended to identify and quantify inorganic and organic compound in human specimens. For in vitro diagnostic use only by trained, qualified laboratory personnel. For in vitro diagnostic applications only.
Indications for use
The TSQ Altis MD Series mass spectrometer will be 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 TSQ Altis MD Series mass spectrometer is to be operated only with hardware or software labeled for in vitro diagnostic use.
Limitations of Use
The TSQ Altis MD triple-stage quadrupole mass spectrometer has been evaluated and determined to be compatible with the following Thermo Scientific instruments:
As a component of an LDT method or workflow, validation of the LDT method or workflow is the responsibility of the clinical laboratory.