NZB · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.5910
Classification
FDA Product Code
NZB
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 866.5910
Review panel
IM
Medical specialty
Microbiology
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.