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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device mass spectrometer for clinical multiplex test systems
Regulation Description Instrumentation for clinical multiplex test systems.
Definition A mass spectrometer for clinical multiplex test systems is a device that is intended to measure and sort multiple signals generated by an assay from a clinical sample. The generated signals are produced by ionizing the compound or biological material under investigation and separating the resulting ions by means of an electrical and magnetic field according to their mass-to-charge ratios. This instrumentation is used with specific assays to comprise an assay test system to measure multiple analytes of a similar chemical nature.
Product CodeOTA
Regulation Number 862.2570
Device Class 2

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