FDA product code QIG: Quality Control Material, Genetics, Rna
QIG is the FDA product code for quality control material, genetics, rna. It is a Class II device, regulated under 21 CFR 866.5910 and reviewed by the Medical Genetics panel. Devices under QIG reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Quality Control Material, Genetics, Rna |
| Device class | Class II |
| Regulation | 21 CFR 866.5910 |
| Review panel | MG — Medical Genetics |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Recalls for QIG devices
openFDA lists no recalls for product code QIG.
Frequently asked questions
What is FDA product code QIG?
QIG is the FDA product code for quality control material, genetics, rna. It is a Class II device, regulated under 21 CFR 866.5910 and reviewed by the Medical Genetics panel.
What device class is QIG?
Class II, regulation 21 CFR 866.5910. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code QIG
- Run a recall and safety report across every QIG manufacturer
- Watch product code QIG for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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