DeviceClearance

Product code OOI— Clinical Chemistry

Revogene

Classification name
Real Time Nucleic Acid Amplification System
Device class
Class 2
Regulation
21 CFR 862.2570
Advisory panel
Clinical Chemistry
Total cleared
14
First cleared
Most recent

FDA classification definition

“The system is a clinical multiplex instrument intended to measure and sort multiple signals generated my multiple probes, intercalating dyes, or other ligands in an assay from a clinical sample. Signals may be generated by fluorescence or other phenomena and may be measured using filters on a photodiode or other detector. It may integrate sample and/or reagent handling, amplification, dedicated instrument control, data acquisition software, raw data storage mechanisms and other essential hardware components along with the signal reader unit. The system is used with specific assays to comprise an assay test system.”

— U.S. Food and Drug Administration, device classification record for product code OOI under 21 CFR 862.2570, via openFDA

Market context for product code OOI

FDA has cleared 14 devices under product code OOI between 2010 and 2025, filed by 10 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code OOI

Adverse events under product code OOI

product code OOI
Malfunction
2,506
Other
3
Total
2,509

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code OOI

Data sourced from openFDA. This site is unofficial and independent of the FDA.