NZB — Quality Control Material, Genetics, Dna Class II
FDA product code NZB covers "Quality Control Material, Genetics, Dna", a Class II medical device regulated under 21 CFR 866.5910. Submissions are reviewed by the Microbiology panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NZB
- Device Class
- Class II
- Regulation Number
- 866.5910
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Microbiology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K093737 | instrumentation laboratory | HEMOSIL F11 & FV DNA CONTROL | May 4, 2010 |
| K083171 | maine molecular quality controls | INTROL CF PANEL I CONTROL, MODEL: G106 | December 16, 2008 |
| K063224 | gentris corporation | GENTRISURE HUMAN GENOMIC DNA REFERENCE CONTROL | December 22, 2006 |
| DEN060007 | maine molecular quality controls | INTROL CF PANEL I CONTROL | October 12, 2006 |