FDA product code OTA

Mass Spectrometer For Clinical Multiplex Test Systems

Clinical Chemistry·Class 2·21 CFR 862.2570
US regulatory classifications
US Product Code (FDA)
OTA
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 862.2570
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Medical specialty
Clinical Chemistry
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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.

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About this record

Mass Spectrometer For Clinical Multiplex Test Systems is a medical device type in the Clinical Chemistry specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.