Mass Spectrometer For Clinical Multiplex Test Systems
- US Product Code (FDA)
- OTAView Product Code Classification →
- US Risk Class (FDA)
- Class 2
- US Regulation (CFR)
- 21 CFR 862.2570View CFR Regulation →
- Medical specialty
- Clinical Chemistry
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Not Eligible
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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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.
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