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Complete Gene Expression Profiling Accessory Reagents

FDA product code OVA · 1 cleared devices

Class 2 Clinical Chemistry
Regulation
21 CFR 862.2570
Review panel
CH
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2011-05-04 – 2011-05-04

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.

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