OVA

Complete Gene Expression Profiling Accessory Reagents

Product code

OVA

Device name

Complete Gene Expression Profiling Accessory Reagents

Device class

Class 2

21 CFR

21 CFR 862.2570

Medical specialty

Clinical Chemistry

Marketing pathway

510(K) Exempt

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification definition

Complete gene expression profiling accessory reagent kits include all components necessary to perform transcript synthesis, fluorescent labeling, and detection and are intended to carry out all processing steps for separately cleared gene expression microarray assays which specify their use. They are designed and optimized for preparation of labeled complementary RNA (cRNA) target using total RNA isolated from specific clinical tissue specimens for hybridization to and measurement of fluorescently-labeled cRNA targets using a specified and cleared microarray instrumentation system. They may also include specified exogenous controls intended to monitor amplification and labeling processes.

Definition text from the FDA device classification database (U.S. federal government work, public domain).