# Quality Control Material, Genetics, Dna
> **Product code: 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.

## Market data
- **Cleared 510(k) submissions:** 4
- **Registered establishments:** 4
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=NZB)
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