NZBClass II

Quality Control Material, Genetics, Dna

21 CFR 866.5910 / Microbiology

NZB is the FDA product code for Quality Control Material, Genetics, Dna, a class II device type, regulated under 21 CFR 866.5910. FDA's definition for this code reads: "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...". As of 2026-09-10, FDA records hold 4 510(k) clearances under this code, the most recent dated 2010-05-04, and no recalls.

Classification record

Product code: NZB
Device name: Quality Control Material, Genetics, Dna
FDA 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.
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: 4
Ingested recalls: 0

Clearances, product code NZB

By decision year

4 clearances under product code NZB with a decision year between 2006 and 2010, 2006 the highest year at 2.

Show the numbers

510(k) clearances under FDA product code NZB by decision year
Year	Clearances
2006	2
2008	1
2010	1

Applicants with the most clearances

Product code NZB

Applicants holding the most 510(k) clearances under product code NZB
Applicant	Clearances
Maine Molecular Quality Controls, Inc.	2
Gentris Corporation	1
Instrumentation Laboratory Co.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

Recent clearances

Product code NZB

Recent recalls

Product code NZB

FDA records show no recalls under product code NZB.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)