Product code NZB

Device name
Quality Control Material, Genetics, Dna
Medical specialty
Microbiology
Device class
2
Regulation number
866.5910
Review panel
IM
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Eligible
Definition
Dna quality control material for genetic testing is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. This type of device includes synthetic dna controls and cell-line based controls.
Source
FDA openFDA device classification dataset