Mass Spectrometer For Clinical Multiplex Test Systems
FDA product code OTA · Class II (moderate risk) · 21 CFR 862.2570 · Clinical Chemistry
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.
0510(k) clearances
0PMA approvals
1recalls
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2362-2026 Class II | Brand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Number: IE800.A…It was reported that plates 2 and 3 were marked as passed , although it appeared that QC had not been… | The Binding Site Group, Ltd. | 04/16/2026Open, Classified |