OUE
- Product code
- OUE
- Device name
- Micro Total Analysis Instrument System
- Device class
- Class 2
- 21 CFR
- 21 CFR 862.2570
- Medical specialty
- Clinical Chemistry
- Marketing pathway
- 510(K) Exempt
FDA classification definition
A micro total analysis instrument system is a clinical multiplex instrument intended to measure and sort signals generated by fluorescently-labeled immune complexes from a clinical sample on a microcapillary chip. Signals may be quantified using laser-induced-fluorescence detection using filters on a photodiode or other detector. It may integrate microfluidic chips with discrete zones for clinical sample and assay reagents; capillary electrophoresis; reagent handling system; dedicated instrument control; data acquisition software; raw data storage mechanisms; and other essential hardware components and signal reader unit. It is used with specific assays to comprise an assay test system.
Official FDA classification page: OUE
Classification and pathway per current FDA publications. Data from openFDA (CC0).