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QIGClass II

Quality Control Material, Genetics, Rna

21 CFR 866.5910 / Microbiology
FDA source (opens on fda.gov)

QIG is the FDA product code for Quality Control Material, Genetics, Rna, a class II device type, regulated under 21 CFR 866.5910. FDA's definition for this code reads: "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...". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
QIG
Device name
Quality Control Material, Genetics, Rna
FDA 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.
Regulation
21 CFR 866.5910
Device class
Class II
Review panel
Microbiology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code