As a component of an LDT method or workflow, validation of the LDT method or workflow is the responsibility of the clinical laboratory.
Intended Use
The TSQ Quantis 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 Quantis MD Series mass spectrometer is compatible with the following Thermo Fisher 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.
Manufacturer Thermo Fisher Scientific
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