QIGClass II
Quality Control Material, Genetics, Rna
Microbiology · 21 CFR 866.5910
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.
MDR events1All time
Recalls0All time
Registered firms1Currently listed
510(k) clearances0All time
Recent MDR events
1 adverse event reports on file
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
1 firms currently registered for this product code
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.