QIG — Quality Control Material, Genetics, Rna Class II
FDA product code QIG covers "Quality Control Material, Genetics, Rna", a Class II medical device regulated under 21 CFR 866.5910. Submissions are reviewed by the Microbiology panel.
Classification Details
- Product Code
- QIG
- Device Class
- Class II
- Regulation Number
- 866.5910
- Submission Type
- Review Panel
- MG
- Medical Specialty
- Microbiology
- Implant
- No
Definition
RNA quality control material for genetic testing is a device intended for medical purposes for use in a test system to estimate test precision or sample concentration and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. This type of device includes synthetic RNA controls and cell-line based controls.